Clinical trial NCT02811302: PRediction of Opioid-induced Respiratory Depression In Patients Monitored by capnoGraphY
Official title: PRediction of Opioid-induced Respiratory Depression In Patients Monitored by capnoGraphY (PRODIGY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Depression
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2016-06-23
Enrollment: 1495
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: PRODIGY is a prospective, multi-center, post-market, international cohort study. The primary objective of this study is to derive a score to identify subjects at risk to have respiratory depression (RD) episodes in patients undergoing opioid therapy in the hospital ward and monitored by capnography. The score will be derived by using subjects within the derivation cohort and internally validated using subjects within the validation cohort.

The primary endpoint used to derive the score will be the occurrence of RD episodes derived by Capnostream 20p device memory data combined with clinical data and validated by an independent Clinical Endpoint Committee (CEC) during the study course.


Eligibility criteria: Inclusion Criteria:

1. Patients receiving parenteral opioid therapy (for post-surgical or non-surgical) pain on the hospital ward.
2. Adult age (≥18 year old in US and Europe; ≥20 years old in Japan; ≥21 years old in Singapore).
3. Patient is able and willing to give informed consent.

Exclusion Criteria:

1. Expected length of stay ≤ 24 hours.
2. Patient is receiving intrathecal opioids.
3. Post-surgical patients with American Society of Anesthesiologists physical status (ASA PS) V or higher.
4. Patients with the status of Do Not Resuscitate (DNR), hospice, or receiving end of life therapy.
5. Ventilated or intubated patients.
6. Patient is unwilling or unable to comply fully with study procedures (including non-toleration of the capnography cannula) due to any disease condition which can raise doubt about compliance and influencing the study outcome.
7. Patient is a member of a vulnerable population, including legal incapacity or evidence that a subject cannot understand the purpose and risks of the study, regardless of authorized representative support.
8. Patient is participating in another potentially confounding drug or device clinical study.

Primary outcomes:
measure: Determine Number of Subjects With RD While on Opioid Therapy
timeFrame: 48 hours
measure: To Derive and Validate a Risk Assessment Tool to Identify Subjects at Risk of Having RD While Undergoing Opioid Therapy on the Hospital Ward
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Royal Oak
country: United States
facility: Beaumont Hospital - Royal Oak
state: Michigan
city: Buffalo
country: United States
facility: Buffalo General Medical Center
state: New York
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Everett
country: United States
facility: Providence Regional Medical Center Everett
state: Washington
city: Suresnes
country: France
facility: Hospital Foch
city: Bonn
country: Germany
facility: University Hospital Bonn
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Tokyo
country: Japan
facility: The Jikei University School of Medicine Hospital
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
state: Limburg
city: Singapore
country: Singapore
facility: National University Hospital
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
Study officials:
affiliation: Roper St. Francis Healthcare
name: Frank J Overdyk
role: STUDY_CHAIR
References:
citation: Overdyk FJ, Carter R, Maddox RR, Callura J, Herrin AE, Henriquez C. Continuous oximetry/capnometry monitoring reveals frequent desaturation and bradypnea during patient-controlled analgesia. Anesth Analg. 2007 Aug;105(2):412-8. doi: 10.1213/01.ane.0000269489.26048.63.
citation: Jarzyna D, Jungquist CR, Pasero C, Willens JS, Nisbet A, Oakes L, Dempsey SJ, Santangelo D, Polomano RC. American Society for Pain Management Nursing guidelines on monitoring for opioid-induced sedation and respiratory depression. Pain Manag Nurs. 2011 Sep;12(3):118-145.e10. doi: 10.1016/j.pmn.2011.06.008.
citation: Cashman JN, Dolin SJ. Respiratory and haemodynamic effects of acute postoperative pain management: evidence from published data. Br J Anaesth. 2004 Aug;93(2):212-23. doi: 10.1093/bja/aeh180. Epub 2004 May 28.
citation: Sun Z, Sessler DI, Dalton JE, Devereaux PJ, Shahinyan A, Naylor AJ, Hutcherson MT, Finnegan PS, Tandon V, Darvish-Kazem S, Chugh S, Alzayer H, Kurz A. Postoperative Hypoxemia Is Common and Persistent: A Prospective Blinded Observational Study. Anesth Analg. 2015 Sep;121(3):709-715. doi: 10.1213/ANE.0000000000000836.
citation: Kor JJ, Sprung J, Khanna AK, Weingarten TN. Continuous Monitoring Detected Respiratory Depressive Episodes in Proximity to Adverse Respiratory Events During the PRODIGY Trial. J Patient Saf. 2022 Dec 1;18(8):738-741. doi: 10.1097/PTS.0000000000001003. Epub 2022 Apr 27.
citation: Sim MA, Seet E, Khanna AK, Weingarten TN, Liew L, Law LS, Liu KE, Di Piazza F, Ti LK; PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Investigators. Association Between Race and Opioid-Induced Respiratory Depression: An International Post Hoc Analysis of the Prediction of Opioid-induced Respiratory Depression In Patients Monitored by Capnography Trial. Anesth Analg. 2022 Nov 1;135(5):1097-1105. doi: 10.1213/ANE.0000000000006006. Epub 2022 Mar 29.
citation: Khanna AK, Jungquist CR, Buhre W, Soto R, Di Piazza F, Saager L; PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Investigators. Modeling the Cost Savings of Continuous Pulse Oximetry and Capnography Monitoring of United States General Care Floor Patients Receiving Opioids Based on the PRODIGY Trial. Adv Ther. 2021 Jul;38(7):3745-3759. doi: 10.1007/s12325-021-01779-7. Epub 2021 May 24.
citation: Khanna AK, Saager L, Bergese SD, Jungquist CR, Morimatsu H, Uezono S, Ti LK, Soto R, Jiang W, Buhre W. Opioid-induced respiratory depression increases hospital costs and length of stay in patients recovering on the general care floor. BMC Anesthesiol. 2021 Mar 20;21(1):88. doi: 10.1186/s12871-021-01307-8.
citation: Urman RD, Khanna AK, Bergese SD, Buhre W, Wittmann M, Le Guen M, Overdyk FJ, Di Piazza F, Saager L. Postoperative opioid administration characteristics associated with opioid-induced respiratory depression: Results from the PRODIGY trial. J Clin Anesth. 2021 Jun;70:110167. doi: 10.1016/j.jclinane.2021.110167. Epub 2021 Jan 22.
citation: Khanna AK, Bergese SD, Jungquist CR, Morimatsu H, Uezono S, Lee S, Ti LK, Urman RD, McIntyre R Jr, Tornero C, Dahan A, Saager L, Weingarten TN, Wittmann M, Auckley D, Brazzi L, Le Guen M, Soto R, Schramm F, Ayad S, Kaw R, Di Stefano P, Sessler DI, Uribe A, Moll V, Dempsey SJ, Buhre W, Overdyk FJ; PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Collaborators. Prediction of Opioid-Induced Respiratory Depression on Inpatient Wards Using Continuous Capnography and Oximetry: An International Prospective, Observational Trial. Anesth Analg. 2020 Oct;131(4):1012-1024. doi: 10.1213/ANE.0000000000004788.
citation: Khanna AK, Overdyk FJ, Greening C, Di Stefano P, Buhre WF. Respiratory depression in low acuity hospital settings-Seeking answers from the PRODIGY trial. J Crit Care. 2018 Oct;47:80-87. doi: 10.1016/j.jcrc.2018.06.014. Epub 2018 Jun 18.