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

Last updated: May 17, 2019
Sponsor: Medtronic - MITG
Overall Status: Completed

Phase

N/A

Condition

Depression

Respiratory Failure

Lung Injury

Treatment

N/A

Clinical Study ID

NCT02811302
COVMOPO0560
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  1. Patients receiving parenteral opioid therapy (for post-surgical or non-surgical) painon the hospital ward.

  2. Adult age (≥18 year old in US and Europe; ≥20 years old in Japan; ≥21 years old inSingapore).

  3. Patient is able and willing to give informed consent.

Exclusion

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 (ASAPS) V or higher.

  4. Patients with the status of Do Not Resuscitate (DNR), hospice, or receiving end oflife therapy.

  5. Ventilated or intubated patients.

  6. Patient is unwilling or unable to comply fully with study procedures (includingnon-toleration of the capnography cannula) due to any disease condition which canraise doubt about compliance and influencing the study outcome.

  7. Patient is a member of a vulnerable population, including legal incapacity or evidencethat a subject cannot understand the purpose and risks of the study, regardless ofauthorized representative support.

  8. Patient is participating in another potentially confounding drug or device clinicalstudy.

Study Design

Total Participants: 1495
Study Start date:
April 07, 2017
Estimated Completion Date:
May 07, 2018

Connect with a study center

  • Hospital Foch

    Suresnes, 92151
    France

    Site Not Available

  • University Hospital Bonn

    Bonn, 53127
    Germany

    Site Not Available

  • Okayama University Hospital

    Okayama, 700-8558
    Japan

    Site Not Available

  • The Jikei University School of Medicine Hospital

    Tokyo, 105-8471
    Japan

    Site Not Available

  • Maastricht UMC+

    Maastricht, Limburg 6229 HX
    Netherlands

    Site Not Available

  • National University Hospital

    Singapore, 119074
    Singapore

    Site Not Available

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • University of Colorado Hospital

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Emory University Hospital

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Beaumont Hospital - Royal Oak

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • Buffalo General Medical Center

    Buffalo, New York 14203
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • MetroHealth Medical Center

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Providence Regional Medical Center Everett

    Everett, Washington 98201-1689
    United States

    Site Not Available

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