Continuous Vital Sign Monitoring in Low Acuity Hospital Settings: Why and How

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1 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

2 Disclosure Consultant; Covidien - Medtronic Respiratory Monitoring Solutions Consultant Medical Director; Qcore Ltd.

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

6 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

7 March 2015, 2012 data Indicator Description Numerator Denominator Observed Rate per 1000 PSI #2 PSI #4 Death Rate on Low-Mortaility DRG s Death Rate among Surgical Inpatients with Serious Treatable Conditions (Cardiac arrest, PE, pneumonia, Sepsis, GI bleed; aka FAILURE TO RESCUE ) 1,822 5,636, , , March ,836 28,703 prescript opioid deaths (2014)

8 PSI #2

9 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 2100 Cardiopulmonary 2135; Fatal anoxic brain injury With permission from patient family

10 Girotra, Saket, et al. "Trends in survival after in-hospital cardiac arrest." New England Journal of Medicine (2012): PSI #4 In-hospital Cardiac Arrest Incidence of cardiac arrest: 1/ 1000 hospital bed days (190,000 in 2012) 38% of survivors had critical anoxic brain injury

11 PSI #4: Better outcomes than expected.

12 PSI #4: Worse outcomes than expected.

13 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): e Opioids/Sedative Use 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

14 Incidence, Location and Reasons for Preventable inhospital Cardiac Arrest in a District General Hospital Hodgetts T, Kenward G, Vlackonikolis I, et. al. Resuscitation 54: (2002) % 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 (2008):

15 Sandra

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18 selecting the right hospital can reduce your risk of avoidable death by 50%

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

20 Rapid Response Teams (RRT) aka Medical Emergency Team Vital Signs q4hr Lab Values Physical Exam EWS Detection of deterioration (Afferent Limb) trigger Intervention (Efferent) Intensivist Critical care nurse Respiratory therapist

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

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

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

24 Tony Left hand finger surgery Dilaudid PCA. Vital signs every 4 hrs Found blue and unresponsive at 5AM Died at age 41 With permission; patient s family

25 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?

26 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) et. al. Event Odds Ratio (95% CI) Bradypnea (RR < 6) 14.4 ( ) Tachypnea (RR > 30) 7.2 ( ) Loss of consciousness 6.4 ( ) Decrease of consciousness 6.4 ( ) Hypotension 2.5 ( ) Hypoxemia (SpO 2 < 90%) 2.4 ( )

27 Clinical antecedents to in-hospital cardiopulmonary arrest. Schein RM, Hazday N, Pena M, Ruben BH, Sprung CL CHEST 1990;98: Respiratory (38%) RR, SpO2 Metabolic (11%) enzymes, lactic acid Cardiac (9%) BP, EKG Neurologic (6%) level of consciousness Multiple (27%) Unknown (9%)

28 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 deterioration 1 Respiratory rate is the least documented vital sign in these systems 2 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 Chen J et al. (2009) The impact of introducing medical emergency team system on the documentations of vital signsresuscitation.80(1):35-43.

29 Matt 13 yo for VP shunt revision D/C PACU 1 pm Peds floor: Dilaudid mg IV q2hr prn Arrested on first POD night With permission; patient s family

30 Continuous oximetry/capnometry monitoring reveals frequent desaturation and bradypnea during patient-controlled analgesia Overdyk, Frank J., et al. Anesthesia & Analgesia (2007): SpO2 PCA ETCO2

31 patients had 1697 hours of continuous SpO 2 and ETCO 2 monitoring SaO2 % 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% HR beats/min 60 PCA Bolus 40 ETCO2 mmhg 20 RR breaths/min 0 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 1.Cashman. Br J Anaesth 2004;93: 2. Walder B. Acta Anaesthesiol Scand 2001;45

32 Continuous capnography/oximetry monitoring during PCA HR beats/min SaO2 % 80 "Code Blue" RR breaths/min 20 ETCO2 mmhg 0 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 Aspiration pneumonia

33 Why not just monitor continuous SpO 2? + suppl O2 Threshold alarm MEWS;MET;RRT Bradypnea (RR<8) Hypoxia (SpO 2 < 90%) Overdyk F, Maddox R, et. al, A&A 2007:105;

34 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)

35 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: % 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).

36 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 O 2 is needed. Applying monitoring selectively based upon risk is likely to miss RD in patients without risk factors

37 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

38 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?

39 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

40 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: SpO 2 Chest excursion Ventilation: P ET CO 2, P tc CO 2, V T, V E, RR Blood pressure: SBP, DBP, MBP Temperature Level of consciousness

41 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

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

43 Photoplethsymography (SpO 2, RR, HR) Xhale Assurance: with permission

44 Capnography (RR, ET CO2, patterns) Covidien Medtronic: with permission

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

46 Bioacoustics: RR Masimo: with permission

47 Impedance plethysmography: RR & Vt Respiratory Motion; with permission

48 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):

49 Rhythm Diagnostic Systems; with permission MultiSense TM Heart rate & variability Oxygen saturation Respiratory rate & depth

50 Piezoelectric sensor: RR, HR Early Sense TM : with permission

51 Impedance Pleth, PPG: Continuous RR, SpO2, HR and NIBP Sotera: with permission

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53 Not a medical device! Sensogram Tech: with permission

54 Sensoscan; with permission

55 Sensoscan; with permission

56 Elfi-Tech; with permission

57 Barriers to adoption of continuous vital sign monitoring Lacking evidence of improved outcomes Disruptive to nursing workflow Too many false alarms Too expensive

58 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: 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

59 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 0500 With permission from family

60 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

61 Wake Forest Baptist Medical Center: Presented at AAMI

62 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: Control Unit Intervention Unit CU-IU post All Units LOS in med/surg unit (days) ICU transfers Baseline (pre) Control (post) p value Baseline (pre) Intervention (post) p value p value p value Transfers / 1000pt Days / 1000pt LOS, mean (median) 1.73 (1.32) 4.48 (2.12) (2.33) 2.45 (1.85) APACHE II score Code blue events n (/1000pt) 6 (3.9) 5 (2.1) (6.3) 2 (0.9) <

63 Alarm fatigue Average number of alerts per 12 hours shifts (for all nurses) Average number of alerts per 12 hours shift per nurse (assuming 6 nurses on shift) Estimated false alerts per nurse per shift

64 ASA II Andy Cholycystectomy at noon on a Saturday Found blue/unresponsive at 5AM on Sunday Hospital acknowledges minor procedural lapses in supervising (nurses)

65 Thank you!

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