PRediction of Opioid-induced Respiratory Depression In Patients Monitored by capnoGraphY
Completed · Not applicable
Conditions studied: Respiratory Depression
In brief
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.
Key facts
- Study ID
- NCT02811302
- Run by
- Medtronic - MITG
- People needed
- 1495
- Starts
- 2017-04-07
- Expected to finish
- 2018-05-07
- Last updated by the study team
- 2019-06-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- University of Colorado Hospital — Aurora, Colorado, United States
- Emory University Hospital — Atlanta, Georgia, United States
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Beaumont Hospital - Royal Oak — Royal Oak, Michigan, United States
- Buffalo General Medical Center — Buffalo, New York, United States
- MetroHealth Medical Center — Cleveland, Ohio, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
- Providence Regional Medical Center Everett — Everett, Washington, United States
- Hospital Foch — Suresnes, France
- University Hospital Bonn — Bonn, Germany
- Okayama University Hospital — Okayama, Japan
- The Jikei University School of Medicine Hospital — Tokyo, Japan
- Maastricht UMC+ — Maastricht, Limburg, Netherlands
- National University Hospital — Singapore, Singapore
- Hospital Clínico Universitario de Valencia — Valencia, Spain
Full record on ClinicalTrials.gov
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