‘-

1

Carla R. Jungquist, PhD, ANP-BC, FAAN

Associate Professor

University at Buffalo School of Nursing

Identification of Patients at

High Risk For Opioid-induced

Respiratory Depression

‘-

2

This webinar is sponsored by the American Society for Pain Management Nursing and Medtronic, Inc.

Conflicts of Interest:

Dr. Jungquist has received salary support from Medtronic, Inc. for her role as University at Buffalo site primary investigator for their PRODIGY study.

Dr. Jungquist was lead author for the 2019 Revisions to the ASPMN Monitoring for Advancing Sedation and Respiratory Depression Clinical Practice Guidelines for the Hospitalized Patient.

Thank you to our sponsors

‘-

3

• Review significance of the problem

• Introduce recommendations for stratifying patient risk

• PRODIGY study

• Recommendations for integration into practice according to the ASPMN Monitoring Guidelines

Objectives

‘-

4

Respiratory Compromise

• describes a deterioration in respiratory function in which there is a high likelihood of decompensation into respiratory failure or death

**Looking to improve patient safety by early detection of patient deterioration by best practices for detecting respiratory compromise.

‘-

5

1. Linde-Zwirble WL, Bloom JD, Mecca RS, Hansell DM. Postoperative pulmonary complications in adult elective surgery patients in the US: severity, outcome and resources use. Crit Care Med. 2010;14: P210. 2. Agarwal SJ, Erslon MG, Bloom JD. Projected incidence and cost of respiratory failure, insufficiency and arrest in Medicare population, 2019. Abstract presented at Academy Health Congress, June 2011. 3. Wier LM, Henke R, Friedman B. Diagnostic Groups with Rapidly Increasing Costs, by Payer, 2001 -2007. Healthcare Cost and Utilization Project. Agency for Healthcare Research and Quality. Statistical Brief #91. June 2010. Available at:

*Provided by Covidien

1. Linde-Zwirble WL, Bloom JD, Mecca RS, Hansell DM. Postoperative pulmonary complications in adult

elective surgery patients in the US: severity, outcome and resources use. Crit Care Med. 2010;14: P210.

2. Agarwal SJ, Erslon MG, Bloom JD. Projected incidence and cost of respiratory failure, insufficiency and

arrest in Medicare population, 2019. Abstract presented at Academy Health Congress, June 2011. 3. Wier

LM, Henke R, Friedman B. Diagnostic Groups with Rapidly Increasing Costs, by Payer, 2001 -2007.

Healthcare Cost and Utilization Project. Agency for Healthcare Research and Quality. Statistical Brief #91.

June 2010. Available at: http://ww.hcupus.ahrq.gov/reports/statbriefs/sb91.pdf 4. Kelley SD, Agarwal S, Parikh N, Erslon M, Morris P. Respiratory insufficiency, arrest and failure among medical patients

‘-

6

Incidence

• American Heart Association Get with the Guidelines – Resuscitation Data

• 320 hospitals

• 44,551 acute respiratory events in U.S. hospitals in 2012

• 86% mortality in those that progressed to cardiac arrest

- characteristics associated with mortality was:

• agonal breathing

• septicemia

• hypotension

Resuscitation. 105:123-9, 2016 08.

‘-

7

Up to 4.2% of all hospitalized patients administered opioids for acute pain will experience some type of opioid related adverse events

Postsurgical patients experiencing opioid-related adverse drug events have:

55% longer hospital stays

47% higher costs associated with their care

36% increased risk of 30-day readmission

3.4 times higher risk of inpatient mortality compared to those with no opioid-related adverse drug events

Opioid-related sentinel events cost the healthcare system $2.5 millionper claim on average as well as contribute to nurse burnout

Significance of OIRD

(Davis et al., 2017; Fouladpour et al., 2016; Herzig, Rothberg, Cheung, Ngo, & Marcantonio, 2014; Kessler, Shah, Gruschkus, & Raju, 2013; Rosenfeld et al., 2016)

5/6

NARCAN

‘-

9

Respiratory Event: Time since last nursing assessment

‘-

10

• American Society of Anesthesiologists Task Force on Acute Pain

• American Society of Enhanced Recovery

• American Society for Pain Management Nursing

• American Pain Society

• Society for Anesthesia and Sleep Medicine

• Anesthesia Patient Safety Foundation

Recommendations to address the problem

‘-

11

‘-

12

Recommendation 1

The panel recommends that pain management strategies be individualized and

aligned with peer-reviewed published evidence-based guidelines and the joint

commission current pain standards (strong recommendation, high-level evidence).

‘-

13

Recommendation 2

The panel recommends that clinicians recognize that all hospitalized

patients receiving systemic (e.g., transdermal, IV, oral) or neuraxial

opioids for acute pain management are at risk of opioid-induced

unintended advancing sedation and opioid-induced respiratory

depression. Some patients are at high-risk for opioid-induced adverse

events (see Table 2) (strong recommendation, high level evidence).

‘-

18

Recommendation 3

The panel recommendations that all patients who will receive opioids

undergo a comprehensive assessment of level of individual risk prior

to initiation of opioid therapy. Ongoing re-assessment of risk that

continues through the trajectory of clinical care is essential (strong

recommendation, moderate level evidence).

‘-

19

Recommendation 4

The panel recommends that ongoing individualized patient-centric

plans of care be based on the patient’s level of risk, which may

change over the course of hospitalization, be developed, revised as

needed, and communicated among all members of the patient care

team (strong recommendation, moderate level evidence).

‘-

20

Recommendation 5

The panel recommends that clinicians identify patients at high-risk of

opioid-induced unintended advancing sedation and opioid-induced

respiratory depression by using evidence-based criteria which

includes the use of validated assessment scales/instruments (strong

recommendation, high level evidence).

https://www.drugabuse.gov/sites/default/files/files/OpioidRiskTool.pdf (ORT)

https://www.jopan.org/article/S1089-9472(15)00070-2/pdf (MOSS)

PRODIGY Risk Prediction Tool (under review)

STOP-BANG Questionnaire

‘-

21

• STOP-BANG questionnaire

• Pre-op sleep studies or nocturnal oximetry study

Stratifying Risk

(Chung et al., 2015; Adams, Butas, & Spurlock, 2015)

‘-

22

• Objective:

Develop a risk stratification score for Opioid induced Respiratory Depression

• Design:

Multisite Observational

• Measures:

Continuous SpO2 + etCO2 for patients receiving parenteral opioids for acute pain.

The PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY –PRODIGY Study

‘-

23

• Enrolled 1,495 adult patients at 16 sites in US, EU, & Asia

• Patients were expected to receive parenteral opioid therapy on the GCF

• Analysis set included 1,335enrolled patients who:

• received opioid therapy on GCF

• started continuous monitoring

Study Design

‘-

24

Measures of OIRD

‘-

25

OIRD episode defined as:

RR ≤ 5 breaths for ≥ 3 continuous minutes

SpO2 ≤ 85% for ≥ 3 continuous minutes

etCO2 ≤15 or ≥ 60 mmHg for ≥ 3 continuous minutes

apnea episode lasting >30 seconds

or any respiratory opioid-related adverse event

Independent Clinical Event Committee adjudicated OIRD episodes

The PRODIGY study - Definition of an OIRD episode

‘-

26

46 potential predictors assessed

PRODIGY Risk Score determined using all significant predictors from multivariate risk prediction model

Predictor Variables Analysis

‘-

27

Rate of RD

episodes:

614/1335

monitored

patients =

46%

Participant CharacteristicsUSA

(n=769)

Europe

(n=254)

Asia

(n=312)

Total

(n=1335)Significance

Age (yrs)

<60 32.8% 16.5% 11.2% 24.6% <.001

≥60 - <70 23.9% 33.9% 39.1% 29.4%

≥70 - <80 13.4% 18.1% 24.0% 16.8%

≥80 3.1% 4.7% 4.2% 3.7%

Sex (Male) 37.3% 49.6% 50.3% 42.7% <.001

BMI (kg/m2)

<20 4.0% 4.0% 11.5% 5.8% <.001

≥20 - <25 18.6% 35.3% 44.2% 27.7%

≥25 - <30 27.0% 32.9% 30.4% 29.0%

≥30 - <35 19.0% 17.5% 11.2% 16.9%

≥35 31.3% 10.3% 2.6% 20.6%

Current Smoker 15.6% 19.3% 9.6% 14.9% .004

Neck circumference(≥17 in M; ≥16 in F)

45.8% 24.9% 5.4% 32.7% <.001

Stop Bang Score Class

Low Risk (0-2) 45.4% 53.1% 57.5% 49.6% <.001

Intermediate Risk (3-4) 35.1% 31.3% 36.5% 34.8%

High Risk (5-8) 19.6% 15.6% 5.8% 15.6%

‘-

28***Opioid naïve was defined as no use of any opioids in patient medication history

Participant CharacteristicsUSA

(n=769)

Europe

(n=254)

Asia

(n=312)

Total

(n=1335)Significance

ASA Physical Status

ASA I 0.5% 13.8% 24.0% 8.7% <.001

ASA II 35.8% 59.8% 66.0% 47.6%

ASA III 60.2% 26.0% 9.9% 41.6%

ASA IV 3.5% 0.4% 0.0% 2.1%

Surgery Demographics

Surgical Patient 90.1% 100.0% 100.0% 94.3% <.001

Length of Surgery (hr)

<2 37.7% 20.9% 27.9% 32.2% <.001

≥2 - <4 40.4% 49.2% 38.1% 41.6%

≥4 21.8% 29.9% 34.0% 26.2%

Opioid Demographics

Opioid Naïve*** 71.7% 88.2% 96.5% 80.6% <.001

Multiple Opioids/Concurrent CNS/Sedating Medication

93.9% 86.6% 98.1% 93.5% <.001

Number of Distinct Opioids

One opioid 9.0% 20.5% 2.6% 9.7% <0.001

Opioid number >1 - <4 58.6% 59.8% 88.8% 65.9% <0.001

Opioid number ≥4 32.4% 19.7% 8.7% 24.4%

‘-

29

PredictorsPatients with ≥ 1 RD

episode (n = 614)

Patients without

RD (n = 721)OR

Significance

(P value)

Age

≥70 - <80 yrs 24.3% 10.4% 4.12 <.001

≥80 yrs 5.5% 2.1% 4.70 .014

Sex (Male) 53.3% 33.7% 2.24 <.001

BMI

≥20 - <25 30.7% 25.2% 1.31 .029

≥35 15.0% 25.4% .64 <.001

Chronic Heart Failure 3.9% 1.5% 2.63 .009

Coronary Artery Disease 7.7% 4.7% 1.68 .025

Hypertension 52.3% 40.4% 1.62 <.001

Diabetes - Type II 18.2% 14.1% 1.35 .043

Kidney Failure 5.4% 2.9% 1.89 .025

Asthma 9.0% 14.8% .56 .001

Number of distinct opioids

Opioid Naive 84.7% 77.1% 1.64 <.001

Opioid number ≥1 - <4 70.2% 62.3% 1.29 .009

‘-

30

PRODIGY Risk Score Distribution

Multivariate Model Predictors

Clinical Characteristic Estimate OR Pr > |t|Points if Clinical

Characteristic = ‘Yes’

Age (≥60 - <70) 0.8077 2.243 <.001 8

Age (≥70 - <80) 1.2323 3.429 <.001 12

Age (≥80) 1.5647 4.781 <.001 16

Sex (M) 0.7550 2.128 <.001 8

Opioid Naïve 0.2912 1.338 .078 3

Sleep Disorders 0.4755 1.609 .018 5

Chronic Heart Failure 0.7494 2.116 .067 7

Sum = PRODIGY Score

PRODIGY Score DistributionLow Risk Intermediate Risk High Risk P value

PRODIGY Score <8 points ≥8 & <15 points ≥15 points

% Pts with RD in Risk Category 24% 42% 65% <.001

Sensitivity --- 0.86 0.52

Specificity --- 0.39 0.77

OR (P value)

ORIL = 2.34;

P<.001

ORHL = 6.07;

P<.001

ORHI = 2.6; P<.001

‘-

31

PRODIGY Model Accuracy = 0.76

Sensitivity

‘-

32

Participants that scored > 8 on the instrument:

• Higher incidence of adverse events

PRODIGY – Secondary Outcomes

‘-

33

Characterize the predictive values of individual parameters:

• end tidal CO2

• SpO2

• respiratory rate

• Integrated Pulmonary Index™ algorithm (etCO2, SpO2, RR, and HR)

PRODIGY – Secondary Outcomes

‘-

34

Summary of PRODIGY findings

• RD episodes are common

• Clinical relevance of the RD episodes is not known, but in this study the participants who experienced these episodes had longer lengths of stay and more clinically relevant rapid response calls.

• Repetitive exposure to RD episodes may contribute to significant morbidity

• Current monitoring standards may not detect these events

• PRODIGY risk score: easy to implement tool for prediction of RD episodes

• Patients rated as high-risk by the PRODIGY score may benefit from proactive bedside interventions and need continuous cardiorespiratory monitoring

‘-

35

Recommendation 6

The panel recommends that clinicians employ evidence-based pain

management that incorporates opioid-sparing and multimodal

analgesia therapies (strong recommendation, high level evidence).

‘-

36

Recommendation 7

The panel recommends that hospital policies and procedures reflect

evidence-based and nationally published standards and ensure 1)

effective communication among all members of the patient care team,

2) adequate and safe staffing ratios, and 3) purposeful hourly

rounding by nursing staff (strong recommendation, weak to high levels

of evidence).

‘-

37

Recommendation 8

The panel recommends that the nature, timing, frequency, and

intensity of monitoring practices be based on ongoing nursing

assessment and re-assessment of patient’s risks and response to

pain therapies. Adaptations to the plan of care are driven by iterative

assessments (strong recommendation, moderate level of evidence).

‘-

38

Recommendation 9

The panel recommends evidence-based systematic nursing

assessments for opioid-induced unintended advancing sedation and

respiratory depression inclusive of 1) level of sedation, 2) respiratory rate

and quality, and 3) oxygen saturation prior to initiation of opioid therapy,

before administering an opioid dose, and at peak effect of opioid and/or

other sedating medication co-administered within the therapeutic window of

an opioid. Systematic nursing assessments should not be replaced with

continuous electronic monitoring (strong recommendation, moderate

level evidence).

‘-

39

Recommendation 10

The panel recommends, that all patients deemed to be at risk for opioid-

induced unintended advancing sedation and opioid-induced

respiratory depression be evaluated for continuous electronic

monitoring (see Table 2); and that the type of electronic monitoring be

appropriate to the condition of the patient, presence of supplemental oxygen

or positive airway pressure therapy, patient’s response to care, patient

comfort and adherence to monitoring device, and the detection capability of

the technology (strong recommendation, weak level evidence).

‘-

40

Oxygenation

• Pulse Oximetry

Ventilation

• Capnography

• Minute Ventilation

• Pulse Oximetry AND Respiratory Rate

• Transcutaneous Carbon Dioxide

Monitoring Devices

‘-

41

Adverse event ending with Anoxic Brain Injury

60

65

70

75

80

85

90

95

100

1 2 3 4 5 6 7 8 9

Intermittent Oxygen Saturation Checks

Pulse Oximetry Over 36 Hours Pulse Ox

‘-

42

What happens when we add supplemental O2?

PACU study -- Slashed vertical lines are doses of opioid

Jungquist, C.R., Chandola, V., Spulecki, C., Nguyen, K.V., Crescenzi, P., Tekeste, D. (2019) “Identifying Patients Experiencing Opioid

Induced Respiratory Depression during Recovery from Anesthesia: The application of electronic monitoring devices. World View in

Evidence Based Nursing, 16 (3) 186-194. http://dx.doi.org/10.1111/wvn.12362

‘-

44

Recommendation 11

The panel recommends the judicious use of naloxone based on

patient evidence of life-threatening adverse events (strong

recommendation, moderate level evidence).

‘-

45

Recommendation 12

The panel recommends clinician education on evidence-based and best practices

for: 1) determining patient risks for opioid-induced unintended advancing sedation

and respiratory depression; 2) best practices on assessing level of sedation and

respiratory status; 3) use of trend monitoring as opposed to threshold monitoring

when evaluating indicators for respiratory status; 4) appropriate use of positive

airway pressure therapy; 5) early implementation of appropriate interventions when

advancing sedation and respiratory depression are imminent: and 6) appropriately

educating patients/ family members who want to know how to participate in safety

efforts. (strong recommendation, weak level evidence).

‘-

46

Recommendation 13

The panel recommends that hospital leadership support the development of practice and

administrative policies and procedures that outline the implementation of strategies focusing on:

1) clinician, patient, and family awareness of and strategies to avoid the problem; 2) education of

clinicians, patient, and family on risk assessment and adaptation of individualized monitoring

procedures and policies; 3) proper training on the use of electronic monitoring systems with

potential use of risk alerts within electronic health record systems. (strong recommendation,

moderate level evidence).

The panel recommends the development of evidence-based policies and procedures that support

clinicians, patients and family members education about the patient’s use of positive airway

pressure devices to treat obstructive sleep apnea and obesity hypoventilation syndrome during

hospitalization. (strong recommendation, weak level evidence).

‘-

47

Thank You!