PRediction of Opioid-induced Respiratory Depression In Patients Monitored by capnoGraphY

NCT02811302 | Completed Results FDA Device

• 1 other identifier: COVMOPO0560
• Study Type: interventional
• Target: 1,495
• Locations: 7 countries
• Sites: 16

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.

Conditions

Respiratory Depression

Outcome Measures

Primary Outcomes (2)

• Determine Number of Subjects With RD While on Opioid Therapy

  Continuous respiratory monitoring using a Capnostream monitor will be included for collecting data for end tidal carbon dioxide (etCO2) and Oxygen saturation (SpO2). Positive RD determination was provided by an independent Clinical Event Committee, by assessing the following parameters: * etCO2 ≤ 15 or ≥ 60 mmHg for ≥ 3 minutes, or * RR ≤ 5 breaths for ≥ 3 minutes, or * SpO2 ≤ 85% for ≥ 3 minutes, or * Apnea episode lasting \> 30 seconds, or * Any respiratory Opioid-Related Adverse Event (rORADE).

  48 hours

• To Derive and Validate a Risk Assessment Tool to Identify Subjects at Risk of Having RD While Undergoing Opioid Therapy on the Hospital Ward

  A risk assessment tool will be derived and validated using the incidence of RD episodes captured by continuous capnography and pulse oximetry measurements recorded on the Capnostream device memory data in conjunction with the clinical data as reported by the investigator.

  48 hours

Study Arms (1)

Patients monitored by capnography

OTHER

Capnography and pulse oximetry monitoring data will be collected for up to 48 hours while patients are on the hospital ward. In addition, a 1-month follow up will be completed.

Device: Capnostream Monitor

Interventions

Capnostream Monitor DEVICE

Capnography and pulse oximetry monitoring data will be collected for up to 48 hours while patients are on the hospital ward. In addition, a 1-month follow up will be completed.

Patients monitored by capnography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Expected length of stay ≤ 24 hours.
• Patient is receiving intrathecal opioids.
• Post-surgical patients with American Society of Anesthesiologists physical status (ASA PS) V or higher.
• Patients with the status of Do Not Resuscitate (DNR), hospice, or receiving end of life therapy.
• Ventilated or intubated patients.
• 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.
• 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.
• Patient is participating in another potentially confounding drug or device clinical study.

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (16)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beaumont Hospital - Royal Oak

Royal Oak, Michigan, 48073, United States

Location

Buffalo General Medical Center

Buffalo, New York, 14203, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Providence Regional Medical Center Everett

Everett, Washington, 98201-1689, United States

Location

Hospital Foch

Suresnes, 92151, France

Location

University Hospital Bonn

Bonn, 53127, Germany

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

The Jikei University School of Medicine Hospital

Tokyo, 105-8471, Japan

Location

Maastricht UMC+

Maastricht, Limburg, 6229 HX, Netherlands

Location

National University Hospital

Singapore, 119074, Singapore

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Related Publications (12)

• 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.

  PMID: 17646499 BACKGROUND

• 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.

  PMID: 21893302 BACKGROUND

• 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.

  PMID: 15169738 BACKGROUND

• 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.

  PMID: 26287299 BACKGROUND

• Doufas AG, Laporta ML, Driver CN, Di Piazza F, Scardapane M, Bergese SD, Urman RD, Khanna AK, Weingarten TN; Prediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Investigators. Incidence of postoperative opioid-induced respiratory depression episodes in patients on room air or supplemental oxygen: a post-hoc analysis of the PRODIGY trial. BMC Anesthesiol. 2023 Oct 4;23(1):332. doi: 10.1186/s12871-023-02291-x.

  PMID: 37794334 DERIVED

• 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.

  PMID: 35405725 DERIVED

• 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.

  PMID: 35350054 DERIVED

• 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.

  PMID: 34031858 DERIVED

• 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.

  PMID: 33743588 DERIVED

• 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.

  PMID: 33493688 DERIVED

• 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.

  PMID: 32925318 DERIVED

• 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.

  PMID: 29936327 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Limitations and Caveats

Inconsistent reporting of opioid dosing frequency and amounts which led to the use of opioid naïve as a predictor, versus dose ranges. The scoring system should be further validated in a different study as an external validation.

Results Point of Contact

• Title: Melanie Crystal, Sr. Clinical Program Manager
• Organization: Medtronic - MITG, RGI

melanie.crystal@medtronic.com

720-435-5737

Study Officials

• Frank J Overdyk

  Roper St. Francis Healthcare

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: June 23, 2016
• Study Start: April 7, 2017
• Primary Completion: May 7, 2018
• Study Completion: May 7, 2018
• Last Updated: June 12, 2019
• Results First Posted: June 12, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); JP (2); US (9); SG (1); ES (1); DE (1); NL (1)