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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
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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
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• 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
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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.
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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
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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.
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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)
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NARCAN
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Respiratory Event: Time since last nursing assessment
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• 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
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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).
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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).
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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).
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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).
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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
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• STOP-BANG questionnaire
• Pre-op sleep studies or nocturnal oximetry study
Stratifying Risk
(Chung et al., 2015; Adams, Butas, & Spurlock, 2015)
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• 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
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• 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
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Measures of OIRD
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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
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46 potential predictors assessed
PRODIGY Risk Score determined using all significant predictors from multivariate risk prediction model
Predictor Variables Analysis
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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%
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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%
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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
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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
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PRODIGY Model Accuracy = 0.76
Sensitivity
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Participants that scored > 8 on the instrument:
• Higher incidence of adverse events
PRODIGY – Secondary Outcomes
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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
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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
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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).
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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).
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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).
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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).
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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).
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Oxygenation
• Pulse Oximetry
Ventilation
• Capnography
• Minute Ventilation
• Pulse Oximetry AND Respiratory Rate
• Transcutaneous Carbon Dioxide
Monitoring Devices
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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
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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
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Recommendation 11
The panel recommends the judicious use of naloxone based on
patient evidence of life-threatening adverse events (strong
recommendation, moderate level evidence).
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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).
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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).
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Thank You!