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

• ClinicalTrials.gov Identifier: NCT02811302
• Recruitment Status: Completed
• First Posted: June 23, 2016
• Results First Posted: June 12, 2019
• Last Update Posted: June 12, 2019
• Sponsor: Medtronic - MITG
• Information provided by (Responsible Party): Medtronic - MITG

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Respiratory Depression	Device: Capnostream Monitor	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1495 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: PRediction of Opioid-induced Respiratory Depression In Patients Monitored by capnoGraphY (PRODIGY)
• Actual Study Start Date: April 7, 2017
• Actual Primary Completion Date: May 7, 2018
• Actual Study Completion Date: May 7, 2018

Arms and Interventions

Arm	Intervention/treatment
Patients monitored by capnography; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Determine Number of Subjects With RD While on Opioid Therapy [ Time Frame: 48 hours ]

   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).
2. To Derive and Validate a Risk Assessment Tool to Identify Subjects at Risk of Having RD While Undergoing Opioid Therapy on the Hospital Ward [ Time Frame: 48 hours ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Colorado

University of Colorado Hospital

Aurora, Colorado, United States, 80045

United States, Georgia

Emory University Hospital

Atlanta, Georgia, United States, 30322

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

United States, Michigan

Beaumont Hospital - Royal Oak

Royal Oak, Michigan, United States, 48073

United States, New York

Buffalo General Medical Center

Buffalo, New York, United States, 14203

United States, Ohio

MetroHealth Medical Center

Cleveland, Ohio, United States, 44109

Cleveland Clinic

Cleveland, Ohio, United States, 44195

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States, 43210

United States, Washington

Providence Regional Medical Center Everett

Everett, Washington, United States, 98201-1689

France

Hospital Foch

Suresnes, France, 92151

Germany

University Hospital Bonn

Bonn, Germany, 53127

Japan

Okayama University Hospital

Okayama, Japan, 700-8558

The Jikei University School of Medicine Hospital

Tokyo, Japan, 105-8471

Netherlands

Maastricht UMC+

Maastricht, Limburg, Netherlands, 6229 HX

Singapore

National University Hospital

Singapore, Singapore, 119074

Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Sponsors and Collaborators

Medtronic - MITG

Investigators

• Study Chair: Frank J Overdyk; Roper St. Francis Healthcare

  Study Documents (Full-Text)

Documents provided by Medtronic - MITG:

Study Protocol  [PDF] November 29, 2016

Statistical Analysis Plan  [PDF] September 18, 2017

More Information

Publications:

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.

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.

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. Epub 2004 May 28. Review.

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):709-15. doi: 10.1213/ANE.0000000000000836.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Review.

• Responsible Party: Medtronic - MITG
• ClinicalTrials.gov Identifier: NCT02811302 History of Changes
• Other Study ID Numbers: COVMOPO0560
• First Posted: June 23, 2016
• Results First Posted: June 12, 2019
• Last Update Posted: June 12, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: No
• Pediatric Postmarket Surveillance of a Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Respiratory Insufficiency; Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders; Respiration Disorders; Respiratory Tract Diseases