mantenimiento de una vvp por mas de 3 dias

7/29/2019 Mantenimiento de Una Vvp Por Mas de 3 Dias

1/31

1

Universidad de los AndesEscuela de EnfermeraMetodologa de la InvestigacinAo 2012

Trabajo de investigacin Sistemtica

Integrantes: Sofa BarrigaAlejandra Pizarro

Florencia VargasVernica VillasecaManuela Zapata

Profesora gua: Mitzi LetelierCurso: Metodologa de la

Investigacin


2/31

2


3/31

3

ndicePregunta clnica4rea clnica la que pertenece...4Contexto en el cual se gener la pregunta.. .4Justificacin.4

Estrategias de bsqueda.4Contenidos, criterios de seleccin y de validez.. ..5Tabla de resumen de bsqueda.. 5Mtodo utilizado para evaluar la validez del estudio ..6Anlisis crtico... 6

Primer estudio; Abstract. 6Gua CASPe/revisin sistemtica... 7

Segundo estudio; Abstract..10Gua CASPe/revisin sistemtica10

Resumen de la evidencia. 13Resumen de la calidad de la evidencia14Conclusin y resolucin de la pregunta. 15Implicancias para la prctica clnica.15Anexos.16Bibliografa

1. PREGUNTA CLNICAEl mantenimiento de una VVP por ms de 3 das v/s el recambio de sta al tercer da,contribuye a la ausencia de complicaciones (extravasacin, infeccin, flebitis) en unpaciente hospitalizado?


4/31

4

2. REA CLNICA A LA QUE PERTENECELa pregunta que se ha escogido se incluye en el rea clnica de terapia/intervencin.

3. CONTEXTO EN EL CUAL SE GENER LA PREGUNTALa pregunta clnica ha surgido desde un comienzo de la carrera de enfermera, ya quecuando se estudia de la teora se establece que una VVP debe permanecer como mximo unperodo de 72 horas. Ya comenzando con las primeras prcticas clnicas, surge la duda decules son los criterios que se deben tomar en cuenta para seguir el protocolo depermanencia y recambio. Se experiment que cada servicio de salud sigue su propioprotocolo, siempre estando dentro de mrgenes adecuados. Se cree que es necesario aplicarpensamiento crtico ante este tipo de situaciones, ya que si se presenta un paciente con unaVVP con permanencia de 72 horas, que se encuentra en buenas condiciones generales, sinsignos de complicaciones y con un mal acceso venoso (por ejemplo), se refuerza que podrano ser necesario el recambio de sta al cumplir el plazo (siempre que sea fundamentado porevidencia cientfica).

4. JUSTIFICACIN1Es muy importante el correcto manejo de una va venosa perifrica (VVP) en el quehacerasistencial de la enfermera, ya que diariamente nos enfrentamos a pacientes con stas. Elprotocolo2es recambiar una VVP cada 72 horas, pero a travs de esta revisin bibliogrficasustentada en la enfermera basada en la evidencia, se evaluar la posibilidad fundamentadatericamente sobre si es posible dejarla por ms de 72 horas sin riesgo de presentarcomplicaciones tales como extravasacin, flebitis y/o infeccin en el sitio de insercin.La enfermera basada en la evidencia es fundamental para nuestro quehacer diario encualquier mbito de la enfermera, ya que se define como uso consciente, explcito yjuicioso de la mejor evidencia clnica disponible para tomar decisiones sobre el cuidado decada paciente. A travs de esta revisin, se realizar una exhausta bsqueda bibliogrficasobre estudios publicados para encontrar la mejor evidencia clnica posible y as modificarel recambio de toda VVP cada 72 horas.

5. ESTRATEGIA DE BSQUEDALos buscadores utilizados principalmente fueron Bireme y Elsevier. Todos de tipo buscadorBase de datos libres.

De todos los estudios encontrados, los que utilizamos son del buscador Bireme y Elsevier,ya que eran ms pertinentes y atingentes a nuestra pregunta clnica.En cuanto a las palabras claves no se utilizaron buscadores especializados en esto, ya quecon las palabras clave (tales como catter venoso perifrico) bastaron para poder encontrar

1 Clases ter icas de Proceso de atencin de Enfermera I I , Pr ofesora I ngr id Bustos, Escuela deEnfermera, Un iversidad de los Andes.

2Protocolo instalacin y manejo va venosa peri frica y manejo de va venosa central. M INSAL,Septiembre 2009.


5/31

5

estudios significativos.

6. CRITERIOS DE SELECCIN Y DE VALIDEZAl ingresar las palabras claves en los buscadores antes mencionados, se ingresaron loslmites para reducir el total de artculos seleccionados, los cuales fueron:

-

En el caso del buscador Elsevier: rea clnica de enfermera y revista de enfermeraclnica. Se encontraron 17 artculos con estos lmites, de los cuales slo seseleccionaron 2 que cumpli con el siguiente requisito: ttulo responde a nuestrapregunta clnica. A los 2 artculos seleccionados se les aplic las preguntas deeliminacin de la gua CASPE para revisiones sistemticas, donde slo 1 aprob.

- En el caso del buscador Bireme: texto completo e idioma ingls. Se encontraron 58artculos, de los cuales 52 no aplicaron ya que el ttulo no responda a la preguntaclnica. Los 6 restantes, se le aplicaron las preguntas de eliminacin de la guaCASPE para revisiones sistemticas, de los cuales, slo se seleccion uno queaprob.

7. TABLA DE RESUMEN DE BSQUEDAFuente Palabras

clavesTotal deartculos

Lmites Totalde art.

Art.seleccionados

Referencia Fec

Elsevier Cattervenosoperifrico.

174 rea clnicadeEnfermera.Revista deenfermeraclnica.

17 1 Mantenimiento decatter venoso perifricodurante ms de 4 das. Enbusca de la mejorevidencia. Juv Udina,Mara Eulalia; CarbonellRibalta, Mara Dolores;Soldevila Casas, RosaMarta; Campa Pulido,Isabel; Jurez Vives,Monserrat.Enferm Clin.2003;13:208-16.

29.

Bireme Cattervenosoperifrico

114 TextocompletoIdioma:ingls

58 1 Clinically-indicatedreplacement versusroutine replacement ofperipheral venouscatheter- Webster J;Osborno S; Rickard C;Hall J; Cochran databasesys rev; (3), 2010.

13.

8. MTODO UTILIZADO PARA EVALUAR LA VALIDEZ DEL ESTUDIOEl mtodo que utilizamos para evaluar la validez de nuestro estudio fue la gua CASPe derevisin sistemtica, la cual adjuntamos ms adelante.

9. ANLISIS CRTICO


6/31

6

ClinicallyIndicated replacement vs routine replacement of very peripheral venouscatheters.3

Abstract

BackgroundCenters forDisease Control Guidelines recommend replacement of peripheral intravenous(IV) catheters every 72 to 96 hours. Routine replacement is thought to reduce the risk ofphlebitis and bacteraemia. Catheter insertion is an unpleasant experience for patients andreplacement may be unnecessary if the catheter remains functional and there are no signs ofinflammation. Costs associated with routine replacement may be considerable.ObjectivesTo assess the effects of removing peripheral IV catheters when clinically indicatedcompared with removing and re-siting the catheter routinely.Search strategyThe Cochrane Peripheral Vascular Diseases Group searched their Specialised Register (lastsearched October 2009) and the Cochrane Central Register of Controlled Trials(CENTRAL) (last searched Issue Issue 4, 2009). We also searched MEDLINE (lastsearched October 2009).Selection criteriaRandomised controlled trials that compared routine removal of peripheral IV catheters withremoval only when clinically indicated in hospitalised or community dwelling patientsreceiving continuous or intermittent infusions.Data collection and analysisThree review authors independently assessed trial quality and extracted data.Main resultsIn five trials (3408 participants) there was a 44% reduction in suspected catheter-relatedbacteraemia in the clinically-indicated group (0.2 versus 0.4%) but this was not statisticallysignificant (odds ratio (OR) 0.57; 95% confidence interval (CI) 0.17 to 1.94; P = 0.37).Phlebitis was assessed in six trials (3455 patients); there was a non-significant increase inphlebitis in the clinically-indicated group (9% versus 7.2%); the OR was 1.24 (95% CI 0.97to 1.60; P = 0.09). We also measured phlebitis per 1000 device days using data from fivetrials, (8779 device days). No statistical differences in the incidence of phlebitis per 1,000device days was found (clinically indicated 1.6 cases per 1,000 catheter days versus 1.5cases per 1,000 catheter days in the routine replacement group).The combined OR was 1.04(95% CI 0.81 to 1.32; P = 0.77). Cost was measured in two trials (961 patients).Cannulation costs were significantly reduced in the clinically-indicated group (meandifference (MD) -6.21; 95% CI -9.32 to -3.11; P = < 0.000).Authors conclusionsThe review found no conclusive evidence of benefit in changing catheters every 72 to 96hours. Consequently, health care organisations may consider changing to a policy wherebycatheters are changed only if clinically indicated. This would provide significant cost

3 Webster Joan, Osborne Sonya, Rickard Claire, Hall Jennifer, ao 2010, Clinically-Indicatedreplacement versus routine replacement of peripheral venous catheters, Cochrane Database ofSystematic Reviews, Issue 10.


7/31

7

savings and would also be welcomed by patients, who would be spared the unnecessarypain of routine re-sites in the absence of clinical indications.

Gua Caspe/r evisin sistemti ca:

Clinically Indicated replacement vs routine replacement of very peripheral venouscatheters.

Seccin A

1. Se hizo la revisin sistemtica sobre un tema claramente definido: Si, ya que la preguntaesta realizada en trminos de cambiar el catter venoso perifrico segn necesidad o rutina.A dems la poblacin de estudio fueron estudios controlados aleatorios y la intervencin escambiar el catter venoso perifrico segn rutina o necesidad. Se especifica tambin que eltipo de material usado para los catteres poda ser cualquiera (tales como metal, plstico,con heparina, entre otros). Los resultados esperados se dividieron en primarios (bacteremia,tromboflebitis y costo econmico) y secundarios (infiltracin, oclusin, numero derecambio de catter por paciente, infeccin local, mortalidad, dolor y satisfaccin). Porultimo se explicita el objetivo del estudio.

2. Buscaron los autores el tipo de artculos adecuado: S, ya que se dirige a la preguntaobjeto de la revisin, todos los artculos buscados por los autores para conformar la revisinsistemtica, son relacionados y dirigidos a la pregunta objeto de la investigacin, la cual esel cambio de VVP a las 72 horas por rutina o segn necesidad. Adems, la pregunta clnicapertenece al rea de intervencin por lo que los mejores estudios en cuanto a evidencia sonlos Ensayos Clnicos Aleatorizados (ECA). En esta revisin sistemtica sol se incluyeronestos diseos.

3. Crees que estaban incluidos los estudios importantes y pertinentes?: S, ya que:Las bases de datos bibliogrficos que se han utilizado son:

o Cochrane Libraryo MEDLINEo EMBASEo CINAHLo AMEDo Relevant Journals in Cochrane Library

El seguimiento de las referencias duro del ao 2004 hasta el ao 2010. Sin embargo, no sedescribe contacto personal con expertos. Tambin es importante destacar que se realiz unabsqueda en estudios no publicados, donde se describe que contactaron a buscadores paraobtener informacin no publicada y evaluar si poda ser potencialmente til. Por ltimo, larevisin sistemtica no estableci restricciones en cuanto al idioma (realizaron unatraduccin inicial de los resmenes para as poder aplicar criterios de inclusin y exclusin,y los que fueron tiles se tradujeron completos).

4. Crees que los autores de la revisin han hecho suficiente esfuerzo para valorar lacalidad de los estudios incluidos?: S, ya que en la seleccin de los estudios participaron 3personas independientes al estudio. Adems luego de la seleccin otros dos participantes


8/31

8

volvieron a revisar los estudios seleccionados segn los criterios de inclusin y exclusin.Los desacuerdos se resolvieron en una discusin con todos los participantes necesarios yfueron revisados por un sexto participante.

5. Si los resultados de los diferentes estudios han sido mezclados para obtener un resultadocombinado, era razonable hacer eso?:No, ya que en este caso se analiza a travs delcriterio de similitud, o sea no se mezclan los resultados por que todos los artculosevaluaron distintas complicaciones, tiempos de infusin, distintos materiales, entre otros.

Seccin B

6. Cul es el resultado global de la revisin?: Los resultados se encuentran claros, ya queestn explcitamente presentados en el artculo, los cuales son los siguientes:

- Los primeros resultados sugieren que los pacientes no se ven adversamenteafectados si la VVP se cambia bajo indicaciones mdicas o por rutina.

- La tasa de bacteremia es similar en ambos tipos de recambio (segn necesitad orutina) 0.0% y 0.6%.

- Un aumento marginal no significativo de flebitis se pudo apreciar en el recambio deVVP segn necesidad. Sin referencias numricas.

- No hubo indicacin en la revisin de que la flebitis es un precursor para bacteremia.- La oclusin de una VVP fue mucho mayor en el recambio segn necesidad y no por

rutina a las 72 horas. Esto es esperable ya que todas las VVP van a fallareventualmente y van a necesitar ser reemplazadas si el tratamiento EV contina.Este resultado no es clnicamente significativo ya que simplemente es un indicadorque ocurre cuando una va permanece por ms tiempo. El tratamiento para laoclusin es cambiar la VVP, por lo que no hay ningn beneficio en cambiar la VVPpor rutina antes que por necesidad ya que en ambos casos se punciona nuevamente.No presenta resultados numricos.

- El costo en el recambio de VVP segn necesidad fue significativamente menor,alrededor de un 11%.

7. Cul es la precisin de los resultados?

Cambiar VVP cuando est indicado segn necesidad reduce el riesgo de bacteremiaen un 43% pero no fue significativo estadsticamente (OR 0,57; IC 95% 0.17 a 1.94;P 0.37).

No hay una significancia estadstica en el aumento de flebitis en un 24% en elrecambio de VVP indicado segn necesidad (OR 1,24; IC 95% 0.97 a 1.6; P 0,09). Los costos fueron significativamente menores en el grupo de recambio de VVPsegn necesidad (mean difference (MD) -6.21; IC 95% -9.32 a -3.11; P menor0.000).

La incidencia de infeccin local no es estadsticamente diferente en el grupo derecambio de VVP segn necesidad (OR 4.99; IC 95% 0.24 a 104.22; P 0.30).

La oclusin de VVP fue significativamente mayor en el grupo de recambio segnnecesidad (OR 1.64; IC 95% 1.05 a 2.56; P 0,03).


9/31

9

En cuanto a la infiltracin hubo un aumento no significativo de un 13% en el grupode recambio de VVP segn necesidad (OR 1.13; IC 95% 0.90 a 1.42; P + 0.28).

Seccin C

8. Se pueden aplicar los resultados en tu medio?: No, ya que el contexto clnico en cuantoa materiales es distinto en Chile. El nico material usado son los teflones de plstico y eneste estudio se incluyen de todo tipo. Adems la variabilidad de paciente a paciente esextremadamente amplia (edad, patologa de base, patologa aguda, medios, nutricin, entreotros). Sin embargo, a pesar de estas aclaraciones, consideramos que se necesita msestudios y bibliografa sobre el tema para poder analizar la correcta aplicabilidad en nuestromedio.

9. Se han considerado todos los resultados importantes para tomar la decisin? S, ya que

evala todas las complicaciones ms comunes que puede presentar una VVP. Adems delos efectos adversos no tan conocidos y comunes, como el costo econmico y lasatisfaccin del paciente.

10. Los beneficios merecen la pena frente a los prejuicios y costes?: S, ya que aunque noest planteado explcitamente en la revisin, los beneficios alcanzados por una estadamayor de tiempo de la va venosa perifrica, supera los prejuicios que ello contrae quopinas?: s, ya que se logr comprobar algunos beneficios que tiene mantener una VVP porms de 72 horas, sobre todo con el tema de los costos, que disminuyeronsignificativamente. Este ltimo punto es muy relevante para la realidad chilena ya quetodos los recursos, tanto econmicos como humanos, son escasos.

Mantenimiento de catteres venosos perifricos durante ms de 4 das. En busca de lamejor evidencia4

Disponible en:

4 Mara Eulalia Juv Udina, Mara Dolors Carbonell Ribalta, Rosa Mara Soldevila Casas, Isabel Campa

Pulido y Montserrat Juarez Vives, publicacin ao 2002 Mantenimiento de catteres venosos perifricos

durante ms de 4 das. En busca de la mejor evidencia. Juv Udina ME.


10/31

10

http://www.elsevier.es/sites/default/files/elsevier/pdf/35/35v13n04a13050935pdf001.pdf

Abstract:Antecedentes: Desde 1981, los Centers for Disease Control and Prevention (CDC)recomiendan sustituir los catteres venosos perifricos cada 3-4 das para disminuir el

riesgo de flebitis, infeccin y bacteriemia de catter.Objetivo: El objetivo de esta revisin sistemtica es determinar la efectividad de estaintervencin mediante la evaluacin de la evidencia cientfica disponible.Material y mtodo: Se realiz una exploracin de diferentes bases de datos electrnicas y serevisaron manualmente varios ndices desde 1981 a 2001. Para identificar los trabajos msrelevantes y descartar los de menor calidad se emple un sistema de evaluacin cualitativaque permiti la discriminacin de tres grupos de estudios, de mayor a menor calidadmetodolgica y, por tanto, de riesgo de sesgo.Resultados y conclusiones: De los originales captados, 12 fueron sometidos a valoracincrtica.Un 33% se clasific como metodolgicamente insuficiente y un 41% obtuvo unapuntuacin intermedia, con lo que sus resultados deban interpretarse con cautela. Lostrabajos cualitativamente ms significativos no demuestran que sea necesario sustituir deforma rutinaria los catteres venosos perifricos, como recomiendan los CDC.

Gua CASPe/ r evisin sistemtica

Seccin A

1. Se hizo la revisin sobre un tema claramente definido? : S.a. Se definen claramente los puntos importantes tales como: poblacin de

estudio (pacientes adultos hospitalizados con CVP), intervencin realizada

(recambio de va venosa perifrica de 3-4 das frente a mantenimiento deesta por ms de 3-4 das), resultados considerados (flebitis, infeccinbacteriana, colonizacin de catter, extravasacin, obstruccin).

2. Buscaron los autores el tipo de artculos adecuados? : S.a. Se dirige a la pregunta de objetivo: todos los artculos incluidos responden a

la pregunta clnica y tienen el diseo adecuado, incluyendo: revisionessistemticas.

3. Crees que estaban incluidos los estudios importantes y pertinentes?: S.a. Hubo inclusin de base de datos tales como: PubMed, Cochrane Library,

MedLine, The Joanna Briggs Institute for Evidence based Nursing and

midwifery, Evidence based Nursing y Centre for Aplied Nursing Research.Adems hubo Fuentes consultadas por bsqueda manual como referenciabibliogrfica de originals y revisin manual de ndices anuales de variasrevistas (British Journal of Nursing, Nursing ed. Espaola, EnfermeraClnica, Enfermera Intensiva y Journal of Hospital Infection).

b. Tambin, hubo seguimiento de la referencia desde Enero de 1981 hastaOctubre del ao 2001.
http://www.elsevier.es/sites/default/files/elsevier/pdf/35/35v13n04a13050935pdf001.pdfhttp://www.elsevier.es/sites/default/files/elsevier/pdf/35/35v13n04a13050935pdf001.pdfhttp://www.elsevier.es/sites/default/files/elsevier/pdf/35/35v13n04a13050935pdf001.pdf


11/31

11

c. No se describe el contacto personal con expertos.d. Existe bsqueda de estudios no publicados como las bsquedas manuales

mencionadas anteriormente.e. Tambin se incluyen estudios con diferentes idiomas (ingls, espaol y

francs).

4. Crees que los autores de la revisin han hecho suficiente esfuerzo para valorar lacalidad de los estudios incluidos? : S.

a. En el estudio se realiza una valoracin cualitiva, expresada en tabla (incluye:muestra bien definida, medidas de control, definicin de los resultados, entreotros).

b. Hubo 3 observadores en el proceso de seleccin.c. Se realiz un anlisis de 66 estudios, de los cuales 54 fueron excluidos por

cumplir con uno o ms de los siguientes puntos: otros catteres,mantenimiento, peditricos, informes/opinin, entre otros. Adems se realiza

una valoracin crtica a los 12 estudios restantes que incluye los mismosaspectos descritos en la valoracin cualitativa. En cuanto a los motivos deexclusin de los artculos se realiz un anlisis, del cual, los estudios conuna puntuacin cualitativa inferior al 50% deban considerarsemetodolgicamente insuficientes, entre 51-75% deban interpretarse conprecaucin y sobre 75% recibiran la mxima consideracin. Para realizaresta calificacin se basaron en la poblacin de estudio, tipo de catter,tcnica de retirada, mantenimiento, flebitis, bacteremia por CVP, edad,ubicacin CVP, entre otros, teniendo cada uno de estos puntos un puntajemximo de 2 puntos.

5. Si los resultados de los diferentes estudios han sido mezclados para obtener unresultado combinado, era razonable hacer eso? :No.

a. El tipo de estudios y de pacientes eran diferentes.b. Los resultados de cada estudio no se exponen claramente.c. Si se discuten los motivos de cualquier posible variacin de resultados, ya

que sealan la dificultad en establecer estndares con respecto a este temapor las diferencias entre los trminos, la variabilidad de los materiales, lascaractersticas de los productos empleados, la forma de prestar cuidados ylos diferentes factores de riesgo.

Seccin B

6. Cul es el resultado global de la revisin?: S.a. Se concluye en este estudio que no es necesario recambiar de forma

sistemtica los CVP cortos cada 3-4 das, aunque igual se refiere haberpocos estudios de calidad que avalen la eficacia de esta intervencin.

b. No hay resultados numricos


12/31

12

c. En el proceso de bsqueda se encontraron 66 estudios potencialmenterelevantes, de estos, 54 fueron excluidos por diferentes razones (otroscatteres, tipos de mantenimiento, estudios en peditricos, informes/cartas/artculos de opinin, otros) y de los 12 restantes, finalmente 3 fueronconsiderados al obtener alta puntuacin en la valoracin crtica.

7. Cul es la precisin del resultado/s? : No.a. No se especifican los intervalos de confianza dentro de la revisin

sistemtica.

Seccin C

8. Se pueden aplicar los resultados en tu medio?: No s. Se utiliz el criterio de perfilde paciente hospitalizado en servicio mdico-quirrgico. En cuanto a laepidemiologa de morbilidades en Chile (obesidad, anorexia, cncer, asma)comparado con los pases incluidos en los estudios, se puede concluir que en Chile,

las principales patologas no concuerdan del todo con las de los pases del estudio(Canad, Estados Unidos, Espaa, Reino Unido, entre otros), por lo tanto podra noser aplicable a nuestra poblacin, dependiendo de la patologa a tratar.

9. Se han considerado todos los resultados importantes para tomar la decisin?: No.a. Se consideran distintas complicaciones que pueden ocurrir como la flebitis,

infecciones, obstruccin, bacteremia, extravasacin, etc. Sin embargo, no seconsidera el costo de la intervencin, el cual posee relevancia al ser uno delos principales factores que incentivara an ms la realizacin de estaintervencin. Adems, es importante considerar la poblacin a la que se estatendiendo (tanto en patologas como en aspecto econmico), el escenario

en conjunto con los recursos de atencin es igual de importante al haber, enalgunos centros de atencin, todos los materiales necesarios para una buenaatencin, as como en otros lugares no se encuentran stos. Es importanteconsiderar tambin la experiencia, la cual podra aportar gran cantidad debeneficios en el minuto del quehacer ya que es una fuente confiable y directade los resultados de las intervenciones.

10.Los beneficios merecen la pena frente a los perjuicios y costes?: S.a. Por una parte disminuiran los costos econmicos que trae consigo el cambio

rutinario (cada 72 horas) del catter venoso perifrico debido a un mayorgasto de material. Tambin, es beneficioso para el paciente reducir lasintervenciones invasivas que se le realizan, las cuales adems podran llevar


13/31

13

a una nueva infeccin por manipulacin (ejemplo: mala preparacin de lapiel).

9. RESUMEN DE LA EVIDENCIA APORTADA POR LOS ARTCULOS (SE

REFIERE AL RESUMEN DE LOS RESULTADOS ARROJADOS POR LOARTCULOS)

- Del primer artculo (Clinically-indicated replacement versus routine replacementofperipheral venous catheter), la evidencia que aporta es:

o Los primeros resultados sugieren que los pacientes no se ven adversamenteafectados si la VVP se cambia bajo necesidad o por rutina.

o La tasa de bacteremia es similar en ambos (segn necesidad o rutina).o Un aumento marginal no significativo de flebitis se pudo apreciar en el

recambio de VVP segn necesidad.o No hubo indicacin en la revisin de que la flebitis es un precursor para la

bacteremia.o La oclusin de una VVP fue mucho mayor en el recambio segn necesidad.

Esto es esperable ya que todas las VVP van a fallar eventualmente y van anecesitar ser remplazadas si el tratamiento EV contina. Este resultado no esclnicamente significativo ya que simplemente es un indicador que ocurrecuando una va permanece por ms tiempo. El tratamiento para la oclusines cambiar la VVP, por lo que no hay ningn beneficio en cambiarla porrutina antes que por necesidad, ya que en ambos casos se puncionanuevamente.

o El costo en el recambio de VVP segn necesidad fue significativamentemenor.

o Dentro de la conclusin del estudio, los autores refieren que no hayevidencia clara de los beneficios del cambio de 72 a 96 horas del CVP. Sinembargo, mencionan que el aumento del tiempo de recambio trae consigobeneficios para el paciente.

- Del segundo estudio (Mantenimiento de catteres venosos perifricos durante msde 4 das. En busca de la mejor evidencia), la evidencia que aporta es:

o Se concluye en este estudio que no es necesario recambiar de formasistemtica los CVP cortos cada 3-4 das, aunque igual refiere haber pocosestudios de calidad que avalen la eficacia de esta intervencin.

o Los autores opinan que la flebitis estara ms fuertemente asociada a losmedicamentos utilizados que al tiempo de permanencia del CVP.

o En este estudio, los autores refieren que, aun que existe mucha bibliografasobre el tema, no existen muchos estudios de calidad que determinen laeficacia de la intervencin, por lo que sera recomendable la realizacin dems estudios sobre el tema. Y que, con la mejor evidencia disponible, no esnecesario el recambio sistemtico de los CVP cada 3-4 das.

10. RESUMEN DE LA CALIDAD DE LA EVIDENCIA ENCONTRADA (SEREFIERE AL RESUMEN DE LA VALIDEZINTERNA Y EXTERNA DE LOS ARTCULOS)


14/31

14

Primer artculo: Clinically-indicated replacement versus routine replacement of

peripheral venous catheter

- Validez interna Tiene validez interna, ya que est bien definida la poblacin deestudio y la intervencin realizada. Adems, tiene un diseo apropiado para la

pregunta clnica (la poblacin son estudios ECA). Se plantean claramente losobjetivos del estudio (conocer los efectos de el recambio del CVP cuando esclnicamente indicado vs el recambio rutinario), hubo seleccin de muestraadecuada y explcita (poblacin: estudios ECA), tambin se especifican los sesosylas conclusiones presentan coherencia en comparacin con los resultados. Las basesde datos utilizadas son reconocidas, tambin se hizo un periodo de seguimiento de 6aos y realizaron bsquedas de estudios no publicados. Por todo esto, se cree queestaban incluidos todos los estudios importantes y pertinentes. Importante destacarque el proceso previo es reproducible y evala la calidad de los estudios incluidos.

- Validez externa En cuanto a la validez externa, se podra decir que todava no esaplicable a nuestro medio, por la diferencia de contexto clnico en cuanto amateriales, ya que el nico material usado para las vas venosas perifricas en Chileson de plstico (teflones) y en este estudio se incluyen de todo tipo. Sin embargo, enel estudio se nombran distintos tipos de teflones, para distintos tipos de pacientes.En este caso, abra que buscar bibliografa y estudios atingentes para cada caso ypatologa del paciente, por lo tanto creemos que no existe suficiente certeza comopara definir si es aplicable a nuestro medio.

Segundo artculo: Mantenimiento de catteres venosos perifricos durante ms de 4 das.

En busca de la mejor evidencia

- Validez interna Tiene validez interna, ya que est definida la poblacin de estudiocomo tambin la intervencin realizada. De igual forma tiene un diseo apropiadopara la pregunta clnica (la poblacin son estudios ECA). Se define claramente lapregunta clnica, los objetivos esperados del estudio. La seleccin de la muestra ylos sesgos son definidos y especificados. Y en cuanto a los resultados vs laconclusin son coherentes. Algunas de las bases de datos utilizadas sonreconocidas, tambin se hizo un periodo de seguimiento de 20 aos y realizaronbsquedas de estudios no publicados. Se considera que los estudios pertinentes yrelevantes fueron incluidos. Y tambin que el estudio es reproducible y se evala lacalidad de los estudios incluidos.

- Validez externa En cuanto a este punto, se podra decir que todava no esaplicable a nuestro medio, ya que la poblacin, en cuanto a pases, tienen unaepidemiologa de patologas ms comunes, distinta a la de Chile, por lo que si sequiere aplicar este estudio a la poblacin chilena, es necesario considerar msevidencia para poder tomar una decisin de la aplicabilidad.

En conclusin para ambos estudios, consideramos que an se necesita ms evidencia decalidad para poder aplicar los resultados obtenidos.


15/31

15

11. CONCLUSIN Y RESOLUCIN DE LA PREGUNTA

A travs de esta revisin sistemtica, se ha encontrado respuesta a la pregunta clnica que se

plante en un principio. A pesar de las pocas referencias bibliogrficas que se encontrarondisponibles, las dos analizadas, llegaron a resultados parcialmente similares (una con msdetalle que la otra). La conclusin general fue que pareciera ser beneficioso y menosriesgoso de lo que se esperaba, mantener una va venosa perifrica por ms de 72 horasmientras est en buenas condiciones.Tambin es importante destacar que aunque se haya llegado a este resultado, an sonescasas las evidencias cientficas significativas que lo avalen, por lo que se recomiendaesperar an ms estudios publicados para poner en prctica las conclusiones a las cuales seha llegado.

12. IMPLICANCIAS PARA LA PRCTICA CLNICA (APLICABILIDAD EN SUPOBLACIN)

Se cree que lo ms importante, teniendo en cuenta las peculiaridades de la poblacin y elpas chileno, debido an a la poca evidencia, es la significativa disminucin de los costoseconmicos, materiales y humanos que trae consigo el cambiar la VVP segn necesidad yno cada 3 o 4 das. Adems, no menos importante, los beneficios que trae para el pacientela reduccin de intervenciones invasivas para l.An as, se recomienda seguir buscando ms evidencia cientfica para poner en prcticaestas acciones debida a la escasa que existe actualmente.

ANEXOS

ESTUDIOS

Clinically-indicated replacement versus routine replacement of peripheral venouscatheters


16/31

16

Editorial group: Cochrane Peripheral Vascular Diseases Group.Publication status and date:New, published in Issue 3, 2010.Review content assessed as up-to-date: 31 January 2010.Citation: Webster J, Osborne S, Rickard C, Hall J. Clinically-indicated replacement versus

routine replacement of peripheral venouscatheters. Cochrane Database of SystematicReviews 2010, Issue 3. Art. No.: CD007798. DOI: 10.1002/14651858.CD007798.pub2.Copyright 2010 The Cochrane Collaboration. Published by JohnWiley & Sons, Ltd.

A B S T R A C TBackgroundCenters for Disease Control Guidelines recommend replacement of peripheral intravenous(IV) catheters every 72 to 96 hours. Routine replacement is thought to reduce the risk ofphlebitis and bacteraemia. Catheter insertion is an unpleasant experience for patients andreplacement may be unnecessary if the catheter remains functional and there are no signs ofinflammation. Costs associated with routine replacement may be considerable.

ObjectivesTo assess the effects of removing peripheral IV catheters when clinically indicatedcompared with removing and re-siting the catheter routinely.

Search strategyThe Cochrane Peripheral Vascular Diseases Group searched their Specialised Register (lastsearched October 2009) and the Cochrane Central Register of Controlled Trials(CENTRAL) (last searched Issue Issue 4, 2009). We also searched MEDLINE (lastsearched October 2009).

Selection criteriaRandomised controlled trials that compared routine removal of peripheral IV catheters withremoval only when clinically indicated in hospitalised or community dwelling patientsreceiving continuous or intermittent infusions.

Data collection and analysisThree review authors independently assessed trial quality and extracted data.

Main resultsIn five trials (3408 participants) there was a 44% reduction in suspected catheter-relatedbacteraemia in the clinically-indicated group (0.2 versus 0.4%) but this was not statisticallysignificant (odds ratio (OR) 0.57; 95% confidence interval (CI) 0.17 to 1.94; P = 0.37).Phlebitis was assessed in six trials (3455 patients); there was a non-significant increase inphlebitis in the clinically-indicated group (9% versus 7.2%); the OR was 1.24 (95% CI 0.97to 1.60; P = 0.09). We also measured phlebitis per 1000 device days using data from fivetrials, (8779 device days). No statistical differences in the incidence of phlebitis per 1,000device days was found (clinically indicated 1.6 cases per 1,000 catheter days versus 1.5cases per 1,000 catheter days in the routine replacement group).The combined OR was 1.04(95% CI 0.81 to 1.32; P = 0.77). Cost was measured in two trials (961 patients).


17/31

17

Cannulation costs were significantly reduced in the clinically-indicated group (meandifference (MD) -6.21; 95% CI -9.32 to -3.11; P = < 0.000).

Authors conclusionsThe review found no conclusive evidence of benefit in changing catheters every 72 to 96

hours. Consequently, health care organisations may consider changing to a policy wherebycatheters are changed only if clinically indicated. This would provide significant costsavings and would also be welcomed by patients, who would be spared the unnecessarypain of routine re-sites in the absence of clinical indications.

P L A I N L A N G U A G E S U M M A R YReplacing peripheral venous catheter when clinically indicated versus routinereplacementMost hospital patients receive fluids or medications via an intravenous catheter at sometime during their hospital stay. An intravenous catheter is a short, hollow tube placed in thevein to allow administration ofmedications, fluids or nutrients directly into the bloodstream(also called a drip). These catheters are routinely replaced every three to four days, to try toprevent infection of the vein or of the blood. However, the evidence to support this practiceis weak. Moreover, the procedure may cause considerable discomfort to patients and isquite costly. This review included all of the randomised controlled trials, which havecompared routine catheter changes with changing the catheter only if there were signs ofinflammation or infection. We found no evidence of benefit from these trials to supportcurrent practice of changing catheters every three to four days.

B A C K G R O U N D

Among hospitalised patients, intravenous therapy is themost common invasive procedure.Intravenous therapy is associated with a phlebitis rate of between 2.3% (White 2001) and60% (Gupta 2007) and an intravenous catheter-related bacteraemia (CRBSI) rate ofapproximately 0.8% (Maki 1991). Current guidelines recommendthat peripheral intravenous (IV) catheters should be resite devery 72 to 96 hours to restrictthe potential of developing phlebitis (O,Grady 2002), and most hospitals follow thisrecommendation. The most recent guidelines state replace peripheral venous catheters atleast every 72 to 96 hours in adults to preventphlebitis (p.762) and carries a category rating of 1B (strongly recommended forimplementation and supported by some experimental, clinical or epidemiological studies).However, the guidelinecites only one observational study to support this recommendation.This was a paper published in 1998 and based on data collected in 1992, which comparedIVs left in place for 72 hours or 96 hours with equivalent phlebitis rates ( Lai 1998).TheGuideline also exempts children or patients with poor veins from the recommendation.In recent years, there have been improvements in catheter design and composition and morerecent studies indicate that the recommendation may need to be revised.

O B J E C T I V E S


18/31

18

To assess the effects of removing peripheral IV catheters when clinically indicatedcompared with removing and re-siting the catheter routinely.

M E T H O D SCriteria for considering studies for this review

Types of studiesAll randomised controlled trials comparing routine removal of peripheral IVcatheters withremoval onlywhen clinically indicated were considered. Cross-over trials were not eligiblefor inclusion.

Types of participantsAny patient requiring a peripheral IV catheter to be in situ for at least three days for theadministration of intermittent or continuous therapy (this may include patients in hospitals,nursing homes or in community settings). Participants receiving parenteral fluids areexcluded.

Types of interventionsAny duration of routine replacement versus clinically-indicated replacement will beincluded. Catheters made from any type of material (e.g. metal, plastic); non-coated orcoated with any type of product (e.g. antibiotic, anticoagulant) or covered by any type ofdressing (e.g. gauze, clear occlusive) were eligible.

Types of outcome measuresPrimary outcomes Suspected device-related bacteraemia (defined as a bacteraemia occurring while the IV isin situ or up to 48 hours post removal, where there are no other clinical or microbiologicaldata to explain the source of the infection). Thrombophlebitis (using any definition identified by the trial author). Cost (in terms of materials and labourassociated with IV catheter-related insertion). Thismay be unavailable in some reports so cost is not an inclusion criteria.

Secondary outcomes Infiltration (defined as permeation of IV fluid into the interstitial compartment, causingswelling of the tissue around the site of the catheter). Catheter occlusion (identified by the inability to infuse fluids). Number of catheter re-sites per patient. Local infection. Mortality. Pain. Satisfaction.Search methods for identification of studies

Electronic searchesThe Cochrane Peripheral Vascular Diseases (PVD) Group searched their SpecialisedRegister (last searched October 2009) and the Cochrane Central Register of Controlled


19/31

19

Trials (CENTRAL) in The Cochrane Library (last searched Issue 4, 2009) for publicationsdescribing randomised controlled trials of routine peripheral IV replacement compared withreplacement based on clinical indications. See Appendix 1 for details of the search strategyused to search CENTRAL.The Specialised Register is maintained by the Trials Search Coordinator and is constructed

from weekly electronic searches of MEDLINE, EMBASE, CINAHL, AMED, and throughhandsearchingrelevant journals. The full list of the databases, journals and conferenceproceedings which have been searched, as well as the search strategies used are describedin the Specialised Registersection of the Cochrane PVD Group module in The CochraneLibrary.The review authors searched the Cochrane Central Register of Controlled Trials(CENTRAL), (The Cochrane Library, issue 4, 2009) using the strategy described inAppendix 2 andMEDLINE (1950 to October 2009) using the search strategy described inAppendix 3.

Searching other resourcesWe contacted researchers and manufacturers in order to obtain any unpublished data.Reference lists of potentially useful articles were also searched.There was no restriction on language. If foreign language studies had been found, weintended to seek initial translation of abstracts for the application of the inclusion andexclusion criteria. Where necessary the methods, results and discussion sections wouldhave been translated for inclusion in the review.

Data collection and analysis

Selection of studiesTitles and abstracts identified through the search process were independently reviewed byJW, SO and CR. Full reports of all potentially relevant trials were retrieved for furtherassessment of eligibility based on the inclusion criteria. As the review authors were also theinvestigators on some of the included trials, assessment was allocated to a review authorwho was not an investigator. Differences of opinion were settled by consensus or referral toa third reviewer. There was no blinding of authorship.

Data extraction and managementFollowing PVD Group recommendations, two review authors independently extracted datato a pre-tested data extraction form. Disagreements were resolved by discussion and wherenecessary, by a third review author. We contacted authors of published and unpublishedtrials for additional information.We extracted the following main sets of data from each includedstudy: lead author; date; study participant inclusion criteria; country where the research was conducted; participants gender and age; study design; randomisation processes; allocationconcealment; intervention descriptions;


20/31

20

intervention setting (hospital, home, residential aged carefacilities); numbers of participants in each trial arm, withdrawals anddropouts; outcome measures; time(s) at which outcomes were assessed

The first reviewauthor entered the data intoRevMan,with anotherreview author checkingthe data entry accuracy.

Assessment of risk of bias in included studiesTwo review authors independently assessed the quality of eligible trials, using the PVDquality assessment criteria outlined below. Disagreements between review authors wasresolved by consensus or referral to a third reviewer. We contacted investigators ofincluded trials to resolve any ambiguities.

Adequacy of the randomisation processA - Adequate sequence generation is reported for example, usingrandomnumber tables,computer randomnumber generator, coin tossing or card shuffling.B - did not specify on the adequate reported methods in (A) but mentioned randomisationmethod.C - Other method of allocation that may not be random.

Adequacy of allocation concealmentA - Adequate: allocation concealment described that would not allow investigators/participants to know or influence intervention group before eligible participant entered inthe study, for example central randomisation, serially numbered, opaque, sealed envelopes.B - Unclear: unclearly concealed trials in which the author either did not report allocationconcealment approach at all, or reported an approach that was not clearly adequate.C- Inadequate: inadequately concealed trials in which themethod of allocation is notconcealed, such as alternation methods or unsealed envelopes; any information in the studythat indicated that investigators or participants could influence intervention group.

BlindingA - Blinding of treatment providers: Yes/No/Unclear.B - Blinding of participants: Yes/No/Unclear.C - Blinding of outcome assessor: Yes/No/Unclear.D - Blinding of data analysis: Yes/No/Unclear.

Intention-to-treat (ITT) analysisA - Yes: Specifically reported by authors that ITT analysis was undertaken and this wasconfirmed on study assessment, or not stated but evident form study assessment that ITTanalysis was undertaken.B - Unclear: Described as ITT analysis but unable to confirm on study assessment, or notreported and unable to confirm by study assessment.C - No: Lack of ITT analysis confirmed on study assessment, for example patients whowere randomised were not included in the analysis because they did not receive the studyintervention, or they withdrew from the study, or were not included because of protocolviolation, regardless of whether ITT reported or not.


21/31

21

Completeness of follow upPercentage of participants for whom data were completed at defined study end-point.

Measures of treatment effect

For individual trials, effect measures for categorical outcomes included odds ratio (OR)with its 95%confidence interval (CI). For statistically significant effects, number needed totreat (NNT), or number needed to harm (NNH), were calculated. For continuous outcomes,the effect measure we used was mean difference (MD) or, if the scale of measurementdiffered across trials, standardized mean difference (SMD), each with its 95% CI. For anymetaanalyses (see below), for categorical outcomes the typical estimates of OR with their95% CI were calculated; and for continuous outcomes the mean difference (MD) or asummary estimate for SMD, each with its 95% CI, was calculated. Data were analysedusing The Cochrane Collaborations Review Manager (RevMan) 5 software.

Unit of analysis issuesIt is inadequate merely to compare longer and shorter dwell IVDs on crude incidence ofcomplications; this does not take into account the cumulative daily risk inherent with IVDuse. There is clearly a per day risk that is present, and grows with each day of IVD dwell,

regardless of how many IVDs are used over the period of therapy. This cannot beextrapolated to mean that restricting (removing) individual IVDs will reduce overall risk.That is, an IVD in situ for seven days has seven days of exposure to risk compared with anIVD in use for only three days, but if the patient requires therapy for seven days in totalthen using multiple catheters over the period may not reduce risk, but merely divide thesame risk between multiple catheters. Appropriate time comparisons need to be made usingstatistics such as Kaplan-Meier analysis, logistic regression or Cox proportional models. Itis vital that the patient is used as the unit of measurement (denominator for comparison),not the IVD. If a patient requires therapy for example, for five days, the patient may haveone catheter used for the entire time, or alternately, multiple IVDs used over the five days.If the multiple catheters are viewed independently they may appear to have lower risk, percatheter, but the total risk for the patient over the five days may be the same.We dealt with this by only including studies where data were available per patient ratherthan per catheter.Where data were not originally analysed in this format we contacted theinvestigators (for example Van Donk 2009) to get these data. Cross-over trials were noteligible. Cluster randomised trials werenot expected in this field.

Dealing with missing dataIf any outcome data remained missing despite our attempts to obtain complete outcomedata from authors, we planned to perform an available-case analysis, based on the numbersof patients for whom outcome data were known. If standard deviations were missing, weplanned to impute them from other studies or, where possible, compute them from standarderrors using the formula SD = SE X pN , where these were available (Higgins 2008).

Assessment of heterogeneityHeterogeneity was assessed visually and by using the chi-squared statistic with significancebeing set at P < 0.10. In addition, the degree of heterogeneitywas investigated by


22/31

22

calculating the I2 statistic Higgins 2008. If evidence of significant heterogeneity wasidentified (> 50%), we explored potential causes and a random-effects approach to theanalysis was used.

Assessment of reporting biases

Reporting bias was assessed using guidelines in Cochrane Handbook for SystematicReviews of Interventions (Higgins 2008). Where sufficient study datawere available forindividual outcomes, funnel plots were inspected for evidence of publication bias.

Data synthesisWhere appropriate, results of comparable trials were pooled using a fixed-effectmodel andthe pooled estimate together with its 95% CI is reported.We conducted a narrative reviewof eligible studies where statistical synthesis of data from more than one study was notpossible or considered not appropriate.

Subgroup analysis and investigation of heterogeneityWe planned to analyse potential sources of heterogeneity using the following subgroupanalyses:1. Type of randomisation (truly randomised versus not reported).2. Concealment of allocation (adequate versus not reported).3. Blinding (patients and clinicians blinded versus open-label).4. Statement of withdrawals and losses to follow up in each group (stated versus not stated).5. Intermittent versus continuous infusion.

Sensitivity analysisWe planned to perform sensitivity analyses to explore the effect of the following criteria:1. Concealment of allocation.2. Size of studies (< 100 patients versus at least 100 patients).3. Duration of follow up.4. Unpublished studies.

R E S U L T SDescription of studiesSee:Characteristics of included studies;Characteristics of excluded studies; Characteristicsof ongoing studies.

Results of the searchThe electronic search identified 198 titles. Two further, unpublished trial were alsoconsidered. Of these, 13 were thought to be potentially useful after titles and abstracts werescreened. Full texts of these papers were retrieved and reviewed against the inclusioncriteria by two of the authors. Because three of the authors of this review were alsoinvestigators in trials under consideration, we allocated the assessment of those trials toreviewers who were not investigators for those particular studies. Seven of the 13potentially useful trials did not meet our inclusion criteria and were excluded. Authors ofall included trials were asked for additional information. Responses were received in allcases.


23/31

23

Included studiesFour published RCTs (Barker 2004; Van Donk 2009; Webster 2007; Webster 2008) andtwo unpublished trials (Rickard 2008; Rickard 2009)met the inclusion criteria (see Table:Characteristics of included studies) for details.Rickard 2009 is the interimanalysis of the

ongoing study Rickard 2010. The six trials involved a total of 3,455 participants withindividual trial sizes ranging between 47 and 1,885. One trial was carriedout in England(Barker 2004) the remaining five trials were Australian(Rickard 2008; Rickard 2009; VanDonk 2009; Webster2007; Webster 2008). Four of the trials were conducted in single- centre, acute inpatientsettings (Barker 2004; Rickard 2008; Webster 2007;Webster 2008), one was amulti-centretrial of three Australian hospitals (Rickard 2009) and one was undertaken in a communitysetting (Van Donk 2009). In five trials (Barker 2004; Rickard 2008; Rickard 2009; Webster2007;Webster 2008) patients were included if they were receiving either continuousinfusions or intermittent infusions for medication therapy, whereas the catheters in the VanDonk 2009 trial were used for intermittent medication therapy only. In two trials(Webster 2007; Webster 2008) the comparison was between routine care (planned three-day changes) and clinically-indicated changes. In the Rickard 2008; Rickard 2009; VanDonk 2009 trials, 72 to 96 hour catheter changes were compared with clinical indicationsand Barker 2004 compared 48 hour changes with removal for clinical indicators such aspain, catheter dislodgement or phlebitis.Five of the trials (Barker 2004; Rickard 2008; Rickard 2009; Webster 2007; Webster 2008)used a standard definition of two or more of the following: pain, warmth, erythema,swelling, or a palpable cord. Barker 2004 further classified phlebitis as either mild,moderate or severe, depending on the area of erythema. VanDonk 2009 included the samesymptoms as other trials but scored them as either one or two depending on severity. Ascore of two or more was classified as phlebitis, consequently a patient may have had onlyone symptom, e.g. pain, to receive a positive diagnosis. Power calculations were reportedby Rickard 2008; Rickard 2009; Webster 2007; Webster 2008 and Van Donk 2009but notby Barker 2004. All of the studies had institutional ethical approval.

Excluded studiesThe Table: Characteristics of excluded studies contains reasons for excluding seven trials.In summary, two were very small studies involving the administration of peripheralparenteral nutrition.Neither trial compared straightforward routine replacement with clinically-indicatedremoval (Kerin 1991; May 1996). One trial, Panadero 2002 compared one group that usedthe same catheter both intraoperatively and postoperatively with a group using twocatheters, one during surgery and one postoperatively. The Haddad 2006 trial compared 72hour changes with 96 hour changes and both the Cobb 1992; and Eyer 1990 trials involvedcentral venous catheters. The other excluded study was not a randomized controlled trial(Arnold 1977).

Risk of bias in included studiesSee individualRisk of Bias tables and (Figure 1; Figure 2).

Allocation


24/31

24

Generation of random allocation sequenceAll of the investigators reported that they used a computer-based sequence generator(Barker 2004; Rickard 2008; Rickard 2009; Van Donk 2009; Webster 2007; Webster2008).Allocation concealment

Sealed envelopes were used for allocation concealment by Barker 2004 and Van Donk2009; the remaining four trials used a central telephone service (Rickard 2008; Rickard2009; Webster 2007; Webster 2008).

BlindingIt was not possible to blind either the participants or the health care providers in any of thetrials.

Outcome assessmentThe chief investigator assessed outcomes in the Barker 2004 trial. In the Van Donk 2009;Webster 2007; and Webster 2008 trials, assessment was made by nurses caring for thepatient, or by a dedicated IV Service nurse. None of the nurses were blinded to the groupallocation but nor were any of them associated with the trial. In the Rickard 2008 and theRickard 2009 trials, outcome assessment was undertaken by a dedicated research nurse,who was also aware of the allocation.

Incomplete outcome dataA flow chart was not provided by Barker 2004, so the number screened and eligible isunclear, nor were any drop outs reported. There was an imbalance in the number ofparticipants reported by group, which may indicate either a failure in the randomizationprocess in such a small trial or incomplete reporting. The number of protocol violations bygroup was not reported. There was complete reporting in the other five trials, all of whichprovided a flow of participant through each stage and used intention-to-treat analysis(Rickard 2008; Rickard 2009; Van Donk 2009; Webster 2007; Webster 2008). In theWebster 2007; Webster 2008; and Van Donk 2009 trials, approximately one third of theparticipants had protocol violations. Primarily, these were in the routine replacementgroups, where catheters were not replaced within the specified time period.

Selective reportingStudy protocols were available for five trials (Rickard 2008; Rickard 2009;VanDonk2009;Webster 2007;Webster 2008) and reporting followed pre-planned analyses. Barker2004 reported onexpected primary outcomes.

Other potential sources of biasIn the Barker 2004 trial, there are two definitions of phlebitis, one of which states that twosymptoms are necessary; yet it appears that erythema alone was diagnosed as phlebitis,with severity based on the area of inflammation.

Effects of interventions


25/31

25

See: Summary of findings for the main comparison Routinely replaced peripheralintravenous catheters for preventing phlebitis and other intravenous catheter relatedcomplications

Routine changes versus clinically indicated (analysed per person)

Suspected catheter related bacteraemia was assessed in five trials (3408 patients) (Rickard2008; Rickard 2009; Van Donk 2009; Webster 2007;Webster 2008); phlebitis in six trials(3455 patients) (Barker 2004; Rickard 2008; Rickard 2009; Van Donk 2009; Webster 2007;Webster 2008); cost in two trials (961 patients) (Webster 2007;Webster 2008); localinfection in three trials (1323 patients) (Rickard 2008; Webster 2007; Webster 2008);catheter blockage in four trials (1523 patients) (Rickard 2008; Van Donk 2009;Webster2007;Webster 2008) and infiltration in three trials (1323 patients) Rickard 2008; Webster2007; Webster 2008). Changing catheters when clinically indicated reduced the suspecteddevice related bacteraemia rate by 43% but this was not statistically significant (odds ratio(OR) 0.57; 95% confidence interval (CI) 0.17 to 1.94; P = 0.37) (Figure 3). Conversely,there was a non-statistically significant increase in phlebitis of 24% in the clinically-indicated group (OR 1.24; 95% CI 0.97 to 1.60; P = 0.09) (Figure 4; Figure 5). This resultwas unaffected by whether the infusion was continuous or intermittent. Cannulation costs(measured in Australian dollars) were significantly reduced in the clinically-indicated group(mean difference (MD) -6.21; 95% CI -9.32 to -3.11; P = < 0.000) (Figure 6). Theincidence of local infection was not statistically different between groups (OR 4.99; 95%CI 0.24 to 104.22; P = 0.30) (Figure 7) but catheter failure due to blockage was higher inthe clinically-indicated group (OR 1.64; 95% CI 1.05 to 2.56; P = 0.03) ( Figure 8). Therewas also a non-significant, 13% increase in the number of catheter failures due toinfiltration in the clinically-indicated group (OR1.13; 95%CI 0.90 to 1.42; P + 0.28) (Figure 9).

Routine changes versus clinically indicated (analysed per 1000 device days)Data from five trials (Rickard 2008; Rickard 2009; Van Donk 2009; Webster 2007;Webster 2008), representing 8779 devicedays, were available for analysis. No statisticaldifferences in the incidence of phlebitis per 1,000 device days was found in any of thetrials. When results were combined theOR was 1.04 (95%CI0.81 to 1.32 P = 0.77) (Figure10).

Routine changes versus clinically indicated (sensitivity analyses)Only two of the planned sensitivity analyses were possible. Five of the six included trialsrecruited over 100 participants Rickard 2008; Rickard 2009; Van Donk 2009; Webster2007; Webster2008); the five trials included a total of 3410 patients.The phlebitis rate was17% higher in the clinically-indicated group but this was not statistically significant (OR1.17; 95% CI 0.90 to 1.51; P = 0.24) Figure 11. Four of the six trials were published(Barker 2004; Van Donk 2009; Webster 2007; Webster 2008). When results from thesetrials were combined (1208 participants), there was a statistically significant increase in thephlebitis rate in the clinicallyindicated group (OR 1.61; 95%CI 1.04 to 2.50; P = 0.03)Figure12.We conducted one post hoc sensitivity analysis using phlebitis as an outcome.Four trials of 3210 were included (Rickard 2008; Rickard 2009; Webster 2007; Webster2008). There was an 11% increase in the rate of phlebitis in the clinically indicated group


26/31

26

when two ormore signs or symptoms were used to define phlebitis (OR 1.11; 95% CI 0.84to 1.48; P = 0.47) but this was not statistically significant Figure 13.

D I S C U S S I O N

Summary of main resultsThis systematic review analysed bacteraemia, phlebitis, other reasons for catheter failureand cost, with the intention of comparing routine catheter changes (between two and fourdays) with replacing the catheter only if clinical signs were apparent.The primary outcomes of this review suggest that patients are not adversely affected if thecatheter is changed on clinical indications rather than routinely, as recommended byCentersofDiseaseControl (O,Grady 2002). The rate of device-related bacteraemia was similar inboth groups, between 0.0% and 0.6%, and comparable to that previously reported inobservational studies (Maki 1991). A marginal but non-significant increase in the phlebitisrate in the clinically-indicated group was apparent when data were analysed by patient butbecame less perceptible when data were analysed per 1,000 device days, which is a moreclinically useful measure. This was also true when we undertook a sensitivity analysis,which included only those trials which diagnosed phlebitis using the well accepteddefinition of two or more signs or symptoms (Maki 1991). In addition, most cases ofphlebitis are mild in nature, requiring either no treatment or removal of the catheter. Therewas no indication in our review that phlebitis was a precursor to bacteraemia.Catheter failure due to blockage was significantly greater in the clinically-indicated group.This could be expected, all catheters will fail eventually and will need to be replaced iftreatment is ongoing. The outcome is not clinically important, it is simply an indicator ofthe longer dwell times in the clinically-indicated group. Since the treatment for a blockedcatheter is replacement of the catheter, it would not be of any benefit to the patient toreplace the catheter earlier, since it would not reduce the need for replacement, and wouldinstead increase the chance of recannulation, since many catheters do not fail over thecourse of IV treatment, even with extended dwell times.Cost was significantly less, around AUD $6, in the clinically-indicated group. This resultwas based on only two studies but results were consistent and intuitively logical (fewercatheters, less clinician time and equipment). Although, this is a seemingly small amount, itcorresponds to approximately 11% of catheter-related expenditure, which may represent aconsiderable saving to organisations with high use.

Overall completeness and applicability ofevidenceTrials included in this systematic review directly addressed the review question and wewere able to conduct a number of metaanalyses. Apart from the Barker 2004 trial, resultsfrom the other five trials were quite similar. Participants were representative of thoseusually managed in health care. They included patients in both acute and communitysettings and measured outcomes important to clinicians and patients, providing usefulexternal validity. It has been suggested that insertion and management by anIV team may explain the inefficacy of routine replacement to prevent complications (Maki2008), yet we saw no effect in trials that had significant numbers inserted by an IV team(Webster 2007; Webster 2008) or trials where insertion was by the general medical andnursing staff (Rickard 2008; Rickard 2009). In all of the trials, except for Barker 2004,standard guidelines were followed for the control group, that is, catheters were changed


27/31

27

between 72 and 96 hours, reflecting usual care. In the Barker 2004 trial, catheters werechanged every 48 hours. None of the trials, except the Rickard 2009 unpublished study,were powered to report on phlebitis alone, and some of the trials were very small. Forexample, the only study that showed statistically lower phlebitis rates in the clinically-indicated group (Barker 2004) involved just 47 people and showeddifferences between the

control and intervention groups that were quite dissimilar to all of the other studies.Five of the six included trials were conducted in Australia; this imbalance is difficult tounderstand. It would be useful to see similar studies fromother health care systems, to testthe robustness of results from this review.

Quality of the evidenceAll of the studies avoided selection bias and ensured allocation concealment. The maindifficulty with all of thetrials was that the outcomewas not able to be blinded.This isbecause itwas necessary to identify the catheter as either routine change or clinicallyIndicated, to prevent inadvertent routine replacement of catheters in the intervention group. Itis unclear if this had any bearing on outcomes, but the authors argue that it is unlikely.Barker 2004 was the only investigator who was directly involved in diagnosing phlebitis; inall of the other studies, either medical staff, ward nurses, IV therapy staff or research nursesevaluated the outcomes. As one author noted, it is routine practice to record reasons forremoval of an intravenous catheter in the medical record, and it is unlikely that such entrieswould be falsified, based on group allocation (Webster 2008).

Potential biases in the review processAlthough the authors were investigators in one or more of the included trials, clearlydescribed procedureswere followed to prevent potential biases in the review process. Acareful literature search was conducted and the methods we used are transparent andreproducible. None of the authors has any conflict of interests.

Agreements and disagreements with other studies or reviewsOur results concur with several prospective observational studies, which found noadditional risk in extending IVD dwell times (Bregenzer 1998; Catney 2001; Homer 1998;White 2001). We believe the reason for this is the similarity in the mean dwell timesbetween the intervention and control arms. Each of the included studieswere pragmatictrials and, in real life, many catheters are not changed within the prescribed time frames.For example in three-day protocols, the 72 hour period may occur in the middle of thenight; or a decisionmay bemade to leave an existing catheter in place, if the patient is duefor discharge the following day, or if they are thought to have poor veins. Conversely, thecathetermay need to be removed early in any clinically-indicated group if the patientscatheter becomes blocked, or infiltration or phlebitis occurs, or the patient is dischargedwithin a couple of days of catheter insertion.Our results also support the guidelines for peripheral catheter replacement in children,which states do not replace peripheral catheters unless clinically indicated (CDC,15;pp761) (O,Grady2002).

A U T H O R S C O N C L U S I O N S


28/31

28

Implications for practiceThe review found no conclusive evidence of benefit for 72 to 96 hour catheter changes.Consequently, health care organisations may consider changing to a policy wherebycatheters are changed only if clinically indicated. This would provide significant costsavings and would also be welcomed by patients, who would be spared the unnecessary

pain of routine re-sites in the absence of clinical indications. Busy clinical staff would alsoreduce time spent on this intervention.

Implications for researchAny future trial should use standard definitions for phlebitis and be sufficiently largeenough to show true differences. Based on results fromthemeta-analysis in this review, atleast 3,000 subjects would be required in each arm of any future trial to show a lowering ofphlebitis rates from 9% to 7% (_ = 0.05 and 80% power). Itwould also be useful to include patient satisfaction as an outcome measure and for trials tobe conducted in a variety of health care systems.

A C K N OWL E D G E M E N T SWe are grateful to HeatherMaxwell, PVD Review GroupManaging Editor, for her supportand speedy responses, and to the editors Mr Paul Tisi and Dr Jackie Price for their usefulcomments.

R E F E R E N C E SReferences to studies included in this reviewBarker 2004 {publ ished and unpubli shed data}Barker P, Anderson ADG, Macfie J. Randomised clinical trial of elective re-siting ofintravenous cannulae. Annals of the Royal College of Surgeons of England2004;86(4):2813.Rickard 2008 {unpubl ished data only}Rickard CM, McCann D, Munnings J, McGrail M. 3rd daily resite of peripheralintravenous devices did not reduce complications compared with removal only on clinicalindication. A randomized controlled trial in a hospital without an IV service. Data on file.Rickard 2009 {unpubl ished data only}Rickard CM, Webster J, Wallis M, Whitby M, Gowardman J, McGrail M. Routine re-sitingcompared with removal only onclinical indication of peripheral intravenous devices: A multi-centre randomised controlledtrial. Data on file.Van Donk 2009 {publ ished and unpubli shed data}Van Donk P, Rickard CM, McGrail MR, Doolan G. Routine replacement versus clinicalmonitoring of peripheral intravenous catheters in a regional hospital in the home program:A randomized controlled trial. Infection Control and Hospital Epidemiology 2009;30(9):9157.Webster 2007 {publ ished and unpubl ished data}Webster J, Lloyd S, Hopkins T, Osborne S, Yaxley M. Developing aResearch base forIntravenous Peripheral cannula re-sites (DRIPtrial). A randomised controlled trial ofhospital in-patients.International Journal of Nursing Studies 2007;44(5):66471.Webster 2008 {publ ished and unpubl ished data}


29/31

29

Webster J, Clarke S, Paterson D, Hutton A, van Dyke S, Gale C, et al.Routine care ofperipheral intravenous catheters versus clinically indicated replacement: randomisedcontrolled trial.BMJ2008; 337:a339.References to studies excluded from this reviewArnold 1977 {publ ished data only}

Arnold RE, Elliot EK, Holmes BH. The importance of frequent examination of infusionsites in preventing postinfusion phlebitis. Surgery, Gynecology and Obstetrics1977;145(1):1920.Cobb 1992 {publ ished data only}Cobb DK, High KP, Sawyer RG, Sable CA, Adams RB, Lindley DA, et al.A controlledtrial of scheduled replacement of central venous and pulmonary-artery catheters. The NewEngland Journalof Medicine 1992;327(15):10628.Eyer 1990 {publ ished data only}Eyer S, Brummitt C, Crossley K, Siegel R, Cerra F. Catheter-related sepsis: prospective,randomized study of three methods of longterm catheter maintenance. Critical CareMedicine 1990;18(10): 10739.Haddad 2006

{publ ished data only}Haddad FG, Waked CH, Zein EF. Peripheral venous catheter inflammation. A randomizedprospective trial.Le Journal MdicalLibanais 2006;54:13945.Kerin 1991 {publ ished data only}Kerin MJ, Pickford IR, Jaeger H, Couse NF, Mitchell CJ, Macfie J. A prospective andrandomised study comparing the incidence of infusion phlebitis during continuous andcyclic peripheral parenteral nutrition. Clinical Nutrition 1991;10(6):315 9.May 1996 {publ ished data only}May J, Murchan P, MacFie J, Sedman P, Donat P Palmer D, et al.Prospective study of theaetiology of infusion phlebitis and line failure during peripheral parenteral nutrition. BritishJournal ofSurgery 1996;83(8):10914.Panadero 2002 {publ ished data only}Panadero A, Iohom G, Taj J, Mackay N, Shorten G. A dedicated intravenous cannula forpostoperative use. Effect on incidence and severity of phlebitis. Anaesthesia2002;57(9):9215.

References to ongoing studiesRickard 2010 {publ ished data only}Rickard CM, Webster J, Gowardman J, Wallis M, McCann D, Whitby M, McGrail M.Routine re-siting compared with removal only on clinical indication of peripheralintravenous devices: A multi-centre randomised controlled trial. Data on file - in theprocess of being analysed.Additional referencesBregenzer 1998Bregenzer T, Conen D, Sakmann P, Widmer AF. Is routine replacement of peripheralintravenous catheters necessary?.Archivesof Internal Medicine 1998;158:516.Catney 2001Catney MR, Hillis S,Wakefield B, Simpson L, Domino L, Keller S, Connelly T, White M,Price D, Wagner K. Relationship between peripheral intravenous catheter dwell time andthe development of phlebitis and infiltration. Journal of Infusion Nursing 2-41. 2001;24:33.


30/31

30

Cornely 2002Cornely OA, Bethe U, Pauls R, Waldschmidt D. Peripheral Teflon catheters: factorsdetermining incidence of phlebitis and duration of cannulation. Infection Control andHospital Epidemiology 2002; 23:24953.Everitt 1997

Everitt NJ, Krupowicz DW, Evans JA, McMahon MJ. Ultrasonographic investigation ofthe pathogenesis of infusion thrombophlebitis.British Journal of Surgery 1997;84:6425.Gupta 2007Gupta A Mehta Y, Juneja R, Trehan N. The effect of cannula material on the incidence ofperipheral venous thrombophlebitis.Anaesthesia 2007;62:113942.Higgins 2008Higgins JPT, Deeks JJ. Selecting studies and collecting data. In: Higgins JPT, Green Seditor(s). Cochrane Handbook for SystematicReviews of Interventions. Wiley-Blackwell,2008.

Homer 1998Homer LD, Holmes KR. Risks associated with 72- and 96-hour peripheral intravenouscatheter dwell times.Journal of IntravenousNursing1998;21:3015.Lai 1998Lai KK. Safety of prolonging peripheral cannula and i.v. tubing use from 72 hours to 96hours.American Journal of Infection Control1998;26:6670.Maddox 1977Maddox RR, Rush DR, Rapp RP, Foster TS, Mazella V, McKean HE. Double-blind studyto investigate methods to prevent cephalothin-induced phlebitis. Americal Journal ofHospitalPharmacy 1977;34:2934.Maki 1991Maki DG, Ringer M. Risk factors for infusion-related phlebitis with small peripheralvenous catheters. A randomized controlled trial. Annals of Internal Medicine1991;114:84554.Maki 2008Maki DG. Improving the safety of peripheral intravenous catheters. BMJ2008;337(7662):1223.Monreal 1999Monreal M, Quilez F, Rey-Joly C, Vega J, Torres T, Valero P, Mach G, Ruiz A, Roca J.Infusion phlebitis in patients with acute pneumonia: a prospective study. Chest1999;115:157680.O,Grady 2002OGrady NP, Alexander M, Dellinger EP, Gerberding JL, Heard SO, Maki DG, Masur H,McCormick RD, Mermel LA, Pearson ML, Raad II, Randolph A, Weinstein RA.Guidelines for the prevention of intravascular catheter-related infections. InfectionControland Hospital Epidemiology 2002;23:75969.Panadero 2002Panadero A, Iohom G, Taj J, Mackay N, Shorten G. A dedicated intravenous cannula forpostoperative use effect on incidence and severity of phlebitis.Anaesthesia 2002;57:9215.Shimandle 1999


31/31

Shimandle RB, Johnson D, Baker M, Stotland N, Karrison T, Arnow PM. Safety ofperipheral intravenous catheters in children. Infection Control and Hospital Epidemiology1999;20:73640. Uslusoy 2008 Uslusoy E, Mete S. Predisposing factors to phlebitis inpatients with peripheral intravenous catheters: a descriptive study.Journal of theAmericanAcademy of Nurse Practitioners 2008;20:17280.

White 2001White SA. Peripheral intravenous therapy-related phlebitis rates in an adult population.Journal of Intravenous Nursing2001;24:1924. _Indicates the major publication for thestudy

ESTUDIO

mantenimiento de una vvp por mas de 3 dias

Documents