continuous vital sign monitoring in low acuity hospital settings

Continuous Vital Sign Monitoring in Low Acuity Hospital Settings: Why

and How

Frank J. Overdyk MSEE, MD

AAMI FOUNDATION REGIONAL EVENT

September 27-28, 2016, Chicago, IL

Disclosure

• Consultant; Covidien - Medtronic Respiratory Monitoring Solutions

• Consultant Medical Director; Qcore Ltd.

Makary, MA. Etal. BMJ 353 (2016): i2139.

AHRQ PSI’s: potentially preventable patient safety incidents PSI 02 Death Rate in Low-Mortality Diagnosis- Related Groups (DRGs)

PSI 03 Pressure Ulcer Rate

PSI 04 Death Rate Among Surgical Inpatients with Serious Treatable Complications

PSI 05 Retained Surgical Item or Unretrieved Device Fragment Count

PSI 06 Iatrogenic Pneumothorax Rate

PSI 07 Central Venous Catheter-related Bloodstream Infection Rate

PSI 08 Postoperative Hip Fracture Rate

PSI 09 Perioperative Hemorrhage or Hematoma Rate

PSI 10 Postoperative Physiologic and Metabolic Derangement Rate

PSI 11 Postoperative Respiratory Failure Rate

PSI 12 Perioperative Pulmonary Embolism or Deep Vein Thrombosis Rate

PSI 13 Postoperative Sepsis Rate

PSI 14 Postoperative Wound Dehiscence Rate

PSI 15 Accidental Puncture or Laceration Rate PSI 16 Transfusion Reaction Count

PSI 17 Birth Trauma Rate – Injury to Neonate

PSI 18/19 Obstetric Trauma Rate – vaginal delivery with/wo instrument

March 2015

Indicator Description Numerator Denominator Observed Rate per 1000

PSI #2 Death Rate on Low-Mortaility DRG’s

1,822 5,636,509 0.32

PSI #4 Death Rate among Surgical Inpatients with Serious Treatable Conditions (Cardiac arrest, PE, pneumonia, Sepsis, GI bleed; aka “ FAILURE TO RESCUE”)

22,014 185,587 118.62

March 2015, 2012 data

_____ 23,836 28,703 prescript opioid deaths (2014)

PSI #2

Rachel

39 y.o. mother; Admitted on a Friday night to med-surg floor with kidney stones

Morphine PCA; standard q4 hour vital sign monitoring

“Increasingly lethargic; snoring and sleeping” @ 2100

Cardiopulmonary arrest @ 2135; Fatal

anoxic brain injury

With permission from patient family

In-hospital Cardiac Arrest

Incidence of cardiac arrest: 1/ 1000 hospital bed days (190,000 in 2012)

Girotra, Saket, et al. "Trends in survival after in-hospital cardiac arrest." New England Journal of Medicine 367.20 (2012): 1912-1920.

38% of survivors had critical anoxic brain injury

PSI #4

PSI #4: Better outcomes than expected…….

PSI #4: Worse outcomes than expected…….

Association of Opioids and Sedatives with Increased Risk of In-Hospital

Cardiopulmonary Arrest. Overdyk FJ, Dowling O, Marino J, et. al.

PLOS ONE 11.2 (2016): e0150214.

Opioids/Sedative Use

2007-1012

Cardiac Arrest

(n=96,554)

No Cardiac

Arrest

(n=12,180,137)

Odds

Ratio* 95% CI

Both Opioid and Sedative 41.0 % 21.8% 3.47 (3.40, 3.54)

Opioid only 28.0% 31.4% 1.81 (1.77, 1.85)

Sedative only 13.8% 14.3% 1.82 (1.78, 1.87)

Neither Opioid Nor Sedative 17.2% 32.6% Ref.

“Low Acuity” Patients Cardiac Arrest

General Care Floor 21,564

Incidence, Location and Reasons for Preventable in-

hospital Cardiac Arrest in a District General Hospital Hodgetts T, Kenward G, Vlackonikolis I, et. al.

Resuscitation 54: (2002) 115-123

– 78% of general care ward cardiac arrests (139) were deemed ‘avoidable’.

– The odds of a potentially ‘avoidable’ cardiac arrest was

5.1 times greater for the general care ward than a monitored setting.

– Patients arresting at night and on weekends: 15% chance of survival until discharge and 89% chance of an hypoxic brain injury. (Peberdy, Mary Ann, et al. "Survival from in-hospital cardiac arrest

during nights and weekends." JAMA 299.7 (2008): 785-792.

Sandra

“…selecting the right hospital can reduce your risk of avoidable death by 50%”

Action: Deploy Rapid Response Teams (RRT) at the first sign of patient decline

“The names of the patients whose lives we save can never be known. Our contribution will be what did not happen to them….." Donald M. Berwick, MD, MPP, Institute for Healthcare Improvement, Dec 2004

Detection of deterioration (Afferent Limb)

Intervention (Efferent)

Vital Signs q4hr Lab Values Physical Exam EWS

trigger

Intensivist Critical care nurse Respiratory therapist

Rapid Response Teams (RRT) aka Medical Emergency Team

AHRQ: Interim Update on 2013 Annual Hospital-Acquired Condition Rate and Estimates of Cost Savings and Deaths Averted From 2010 to 2013

AHRQ: Interim Update on 2013 Annual Hospital-Acquired Condition Rate and Estimates of Cost Savings and Deaths Averted From 2010 to 2013

Identifying the hospitalised patient in crisis”—A consensus Conference on the Afferent limb of Rapid Response Systems DeVita M, Smith GB, Adam SK et.al.

Resuscitation 81 (2010) 375–382

vital sign aberrations predict risk

monitoring patients more effectively may improve outcome, although some risk is random

There was agreement that, if practical and affordable, all

patients should be monitored continuously. concern that current technology is clinically inadequate due to

a potential for high false positive or false negative rates

the workload implications of monitoring on the clinical workforce have not been explored

With permission; patient’s family

Left hand finger surgery

Dilaudid PCA.

Vital signs every 4 hrs

Found blue and

unresponsive at 5AM

Died at age 41

Tony

Why should we monitor continuously?

What do we monitor continuously?

Who do we monitor continuously?

How do we monitor continuously?

Where do we monitor continuously?

✓

Extremes of respiration rate are strong predictors of in-hospital mortality on the general ward

Buist M, Bernard S, Nguyen T, Moore G, Anderson J. Resuscitation 62 (2004) 137–141 et. al.

Event Odds Ratio (95% CI)

Bradypnea (RR < 6) 14.4 (2.6 - 80.0)

Tachypnea (RR > 30) 7.2 (3.9 - 13.2)

Loss of consciousness 6.4 (2.9 - 13.6)

Decrease of consciousness 6.4 (2.6 - 15.7)

Hypotension 2.5 (1.6 - 4.1)

Hypoxemia (SpO2 < 90%) 2.4 (1.6 - 4.1)

Clinical antecedents to in-hospital cardiopulmonary arrest.

Schein RM, Hazday N, Pena M, Ruben BH, Sprung CL

CHEST 1990;98:1388-1392

Respiratory (38%) RR, SpO2 Metabolic (11%) enzymes, lactic acid Cardiac (9%) BP, EKG Neurologic (6%) level of consciousness Multiple (27%) Unknown (9%)

Early Warning Score (EWS) Systolic blood pressure, heart rate, temperature, respiratory rate, [oxygen saturation,

level of consciousness]

Respiratory rate found to be best discriminator of all physiological data to identify patients at risk of deterioration1

Respiratory rate is the least documented vital sign in these systems2

1. Subbe CP et al. (2003) Effect of introducing the Modified Early Warning score on clinical outcomes, cardio-pulmonary arrests and intensive care utilisation in acute medical admissions. Anaesthesia, 58, pages 775–803

2. Chen J et al. (2009) The impact of introducing medical emergency team system on the documentations of vital signsResuscitation.80(1):35-43.

Matt

13 yo for VP shunt revision D/C PACU 1 pm Peds floor: Dilaudid 0.5-1.0 mg IV q2hr prn Arrested on first POD night

With permission; patient’s family

Continuous oximetry/capnometry monitoring reveals frequent desaturation and bradypnea during patient-controlled analgesia

Overdyk, Frank J., et al. Anesthesia & Analgesia 105.2 (2007): 412-418.

PCA SpO2 ETCO2

Respiratory Depression Overdyk et. al. Cashman et. al. Walder et. al.

SpO2 < 90% > 2 min 24% 11.5% 15.2%

RR < 10 bpm > 2 min 74% 1.2% 1.6%

1.Cashman. Br J Anaesth 2004;93: 2. Walder B. Acta Anaesthesiol Scand 2001;45

92 patients had 1697 hours of continuous SpO2 and ETCO2 monitoring

0

20

40

60

80

100

120

1/31/06 23:45 2/1/06 0:57 2/1/06 2:09 2/1/06 3:21 2/1/06 4:33

SaO2 %

HR beats/min

PCA Bolus

ETCO2 mmHg

RR breaths/min

0

20

40

60

80

100

120

140

160

2/3/06 18:43 2/3/06 18:57 2/3/06 19:12 2/3/06 19:26 2/3/06 19:40 2/3/06 19:55 2/3/06 20:09

HR beats/min

SaO2 %

"Code Blue"

RR breaths/min

ETCO2 mmHg

Continuous capnography/oximetry monitoring during PCA

Aspiration pneumonia

Why not just monitor continuous SpO2?

Threshold alarm

MEWS;MET;RRT

Bradypnea (RR<8)

Hypoxia (SpO2 < 90%)

Overdyk F, Maddox R, et. al, A&A 2007:105;412-18.

+ suppl O2

Louise

65 y.o. grandmother for elective total knee arthroplasty, opioid naïve

Postop pain plan: Femoral nerve catheter, OnQ and morphine PCA

Orders: Vital signs incl RR and SpO2 every 4 hours

Found Dead in Bed at 4AM

With permission from family (see LouiseBatz.org)

Postoperative Hypoxemia Is Common and Persistent: A Prospective Blinded Observational Study

Zhuo Sun, MD,* Daniel I. Sessler, MD,*† Jarrod E. Dalton, PhD, et.al. Anesth Analg 2015;121:709–15

37% of patients had an SpO2 <90% for an hour or more.

The nurses were unaware of 90% of hypoxemic episodes (SpO2 <90% for at least one hour).

Anesthesia Patient Safety Foundation

2006 Conference:

• No patient shall be harmed by undetected respiratory depression (zero tolerance)

• Continuous monitoring could prevent significant patient harm

2011 Conference: Essential Monitoring Strategies to Detect Clinically Significant Drug-Induced Respiratory Depression

• All patients should be monitored by continuous pulse oximetry.

• Monitoring the adequacy of ventilation and airflow when suppl O2 is needed.

• Applying monitoring selectively based upon risk is likely to miss RD in patients without risk factors

Joint Commission Sentinel Event Alert #49 “Safe Use of Opioids in Hospitals” Aug, 2012

Root causes of preventable harm:

Lack of knowledge about potency differences among opioids.

Improper prescribing and administration of multiple opioids and modalities.

Inadequate monitoring of patients on opioids

Why should we monitor continuously?

What do we monitor continuously?

Who do we monitor continuously?

How do we monitor continuously?

Where do we monitor continuously?

✓

✓

JC SEA #49: Characteristics of patients at higher risk factors for oversedation and respiratory

depression (Aug 2012)

Sleep disorder/snoring (obstructive sleep apnea)

Morbid obesity (assoc w OSA)

Older age: >62 yo……

Opioid naïve

Opioid tolerant (> 60 mg/day morphine 1+ week)

Co-administration of sedatives

Smoking

Pre-existing pulm/cardiac disease;

Long anesthesia/surgery

Non invasive monitoring Technologies

• Photoplethysmography (PPG)

• Impedance plethysmography

• IR detectors (capnography)

• Nasal pressure transducers

• Thermistors

• Bioacoustics

• Piezoelectric

• Severinghaus electrode

• Laser

• Processed EEG

Vital Signs

• Oxygenation: SpO2

• Chest excursion

• Ventilation: PET CO2, PtcCO2, VT, VE , RR

• Blood pressure: SBP, DBP, MBP

• Temperature

• Level of consciousness

How do we monitor continuously on a ‘low’ acuity ward?

• Clinical Acceptability – Ergonomics

• Unencumbering

– Nursing workflow • Initiation monitoring

• Charting

• Actionable interventions

– Alarm Fatigue • Alarm threshold settings

• Notification

JC SEA #50: Medical Device Alarm Safety in Hospitals (April 2013)

• 2009 – 2012 98 alarm related events

– 80 resulted in death

– 15 resulted in permanent disability

– 3 resulted in extended stay/care

• Major contributing factors

– 30 inadequate alarm system

– 21 improper alarms settings

– 25 alarms inaudible

– 36 alarms inappropriately turned off

Photoplethsymography (SpO2, RR, HR)

Xhale Assurance: with permission

Capnography (RR, ETCO2, patterns)

Covidien Medtronic: with permission

* sleeping & snoring * awake *sleeping & not snoring * awakening

Bioacoustics: RR

Masimo: with permission

Impedance plethysmography: RR & Vt

Respiratory Motion; with permission

The evaluation of a non-invasive respiratory volume monitor in surgical patients undergoing elective surgery with general anesthesia. Christopher J. Voscopoulos • C. Marshall MacNabb • Jordan Brayanov • Lizeng Qin • Jenny Freeman • Gary John Mullen • Diane Ladd • Edward George

Journal of clinical monitoring and computing 29.2 (2014):

• Heart rate & variability • Oxygen saturation • Respiratory rate & depth

MultiSenseTM

Rhythm Diagnostic Systems; with permission

Piezoelectric sensor: RR, HR

Early SenseTM: with permission

Sotera: with permission

Impedance Pleth, PPG: Continuous RR, SpO2, HR and NIBP

Sensogram Tech: with permission

Not a medical device!

Sensoscan; with permission

Sensoscan; with permission

Elfi-Tech; with permission

Barriers to adoption of continuous vital sign monitoring

• “Lacking evidence of improved outcomes”

• “Disruptive to nursing workflow”

• “Too many false alarms”

• “Too expensive”

Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers. A Before-and-After Concurrence Study

Taenzer AH, Pyke JB, McGrath SP, Blike GT. Anesthesiology 2010, 112: 282-7

Methods: Before/after implementation in a 36-bed orthopedic unit.

Results:

• 50% reduction in transfers to higher levels of care

• 60% reduction in rescue events

• 0 Dead in Beds

Alarms:

• alarm rates 2-4 per patient per 12 hour shift.

• 85% of all alarm conditions are resolved w/i 30 sec

Financial:

• $85 per patient deployment year; $22 per patient

© 2015 Dartmouth-Hitchcock With permission

Bob

63 y.o. BMI=38; Hx of OSA – home CPAP

Laparoscopic hiatal hernia repair

Morphine PCA; standard q4 hr vital signs

Ambulates to outside facility for UGI

Returns for one more night in hospital; PCA restarted (error)

12 MN; Snoring; spot check SpO2 = 92%; 2L O2 N/C added

Cardiopulmonary arrest @ 0500

With permission from family

• A total of 1,500 patients were monitored for 60,000 hours

• At least 19 events that would have likely resulted in failure to rescue: PE’s, sepsis, MI’s

Wake Forest Baptist Medical Center: Presented at AAMI

Wake Forest Baptist Medical Center: Presented at AAMI

Continuous Monitoring in an Inpatient Medical-Surgical Unit: A Controlled Clinical Trial

Brown H, Terrence J, Vasquez P, Bates DW, Zimlichman E. Am J Med. 2014;127:226-32.

Control Unit Intervention Unit CU-IU

post

All

Units

Baseline (pre) Control (post) p value Baseline (pre) Intervention

(post) p value p value p value

LOS in med/surg unit

(days) 3.80 3.61 0.26 4.00 3.63 0.03 0.91 0.10

ICU transfers

Transfers / 1000pt 18.89 19.06 1.00 26.52 25.93 0.92 0.12 0.21

Days / 1000pt 32.69 85.36

0.01

120.11 63.44

0.05 0.02 0.014 LOS, mean (median) 1.73 (1.32) 4.48 (2.12) 4.53 (2.33) 2.45 (1.85)

APACHE II score 13.08 14.06 0.59 15.19 13.38 0.25 0.61 0.65

Code blue events n

(/1000pt) 6 (3.9) 5 (2.1) 0.36 9 (6.3) 2 (0.9) <0.01 0.45 0.02

Alarm fatigue

12 Average number of alerts per 12 hours shifts (for all nurses)

2 Average number of alerts per 12 hours shift per nurse (assuming 6 nurses on shift)

0.60 Estimated false alerts per nurse per shift

Andy

ASA II

Cholycystectomy at

noon on a Saturday

Found

blue/unresponsive at

5AM on Sunday

Hospital acknowledges

“minor procedural

lapses in supervising

(nurses)”

Thank you!