Journal of Physiotherapy 61 (2015) 93

J o u rn a l o f

PHYSIOTHERAPYjournal homepage: www.e lsev ier .com/ locate / jphys

Appraisal

Trial Protocol

Efficacy of the addition of positive airway pressure to conventional chestphysiotherapy in resolution of pleural effusion after drainage:

protocol for a randomised controlled trial

Elinaldo da Conceicao dos Santos a,b, Adriana Claudia Lunardi a,c

a Master’s and Doctoral Programs in Physical Therapy, Universidade Cidade de Sao Paulo; b Department of Biological and Health Sciences, Universidade Federal do Amapa;c Department of Physical Therapy of School of Medicine, University of Sao Paulo, Sao Paulo, Brazil

Abstract

Introduction: Chest drainage for pleural effusion can cause painand changes in respiratory function. It can also increase the risk ofpulmonary complications and impair functional ability, which mayincrease length of hospital stay and the associated costs. For thesereasons, surgical and clinical strategies have been adopted toreduce the duration of chest drainage. Objectives: To evaluate theefficacy of the addition of intermittent positive airway pressureapplied by the Muller reanimator via a rubber facial mask versusconventional physiotherapy on the duration of chest drainage(primary objective), and its effect on the recovery of respiratoryfunction, length of hospital stay and incidence of pulmonarycomplications (secondary objectives). Design: Randomised, con-trolled trial. Participants and setting: Inpatients with pleuraleffusion, aged over 18 years, who have had chest drainage in situfor < 24 hours will be recruited from two university hospitals.Patients will be excluded if they have any contraindication for theuse of non-invasive positive airway pressure. Intervention andcontrol groups: After initial assessments of lung function,156 patients will be randomised into a positive airway pressuregroup (positive airway pressure at 15 cmH2O plus conventionalchest physiotherapy), a conventional chest physiotherapy group(conventional chest physiotherapy plus non-therapeutic positiveairway pressure at 4 cmH2O) or a control group (non-therapeuticpositive airway pressure at 4 cmH2O). All groups will receivetreatment three times per day for 7 consecutive days. Measure-ments: A blinded assessor will conduct all assessments. Peripheraloxygenation and chest drainage output will be measured over7 consecutive days. Lung function will be re-assessed on Day 4 andDay 8. The criteria for removal of the chest drain will be atransudate output � 200 ml over 24 hours and full lung expansion

http://dx.doi.org/10.1016/j.jphys.2014.11.016

1836-9553/� 2014 Australian Physiotherapy Association. Published by Elsevier B.V. Al

on chest radiography, as assessed by a blinded physician. Duration ofchest drainage, length of hospital stay, and any pulmonarycomplications diagnosed during hospitalisation will be recorded.Analysis: Intention to treat using: survival analysis for duration ofchest drainage, and length of hospital stay; analysis of variance forchest-tube output, lung function and peripheral oxygen saturation;and chi-square tests for comparing the incidence of pulmonarycomplications between groups. Discussion: Conventional chestphysiotherapy and intermittent positive airway pressure breathingare widely indicated for people with pleural effusion and chestdrains; however, no studies have evaluated the real benefit of thistype of treatment. Our hypothesis is that optimised lung expansionachieved through the application of intermittent positive airwaypressure will accelerate the reabsorption of pleural effusion,decrease the duration of chest drainage and respiratory systemimpairment, reduce the length of hospital stay, and reduce theincidence of pulmonary complications.

Trial registration: ClinicalTrials.gov. Registration number:NCT02246946. Was this trial prospectively registered: Yes, date:16 September 2014. Funded by: Conselho Nacional de Desenvolvi-mento Cientıfico e Tecnologico-CNPq. Funder approval number:442709/2014-5. Anticipated completion: September 2016. Corre-spondence: Dr Adriana Claudia Lunardi, Master’s and Doctoral Pro-grams in Physical Therapy, Universidade Cidade de Sao Paulo, SaoPaulo, Brazil. Email: adriana.lunardi@unicid.edu.br

Full protocol: Available on the eAddenda at doi:10.1016/j.jphys.2014.11.016

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