N/A
Completed N=1,495
PRediction of Opioid-induced Respiratory Depression In Patients Monitored by capnoGraphY
Source: ClinicalTrials.gov NCT02811302 ↗Enrolled (actual)
1,495
Serious AEs
9.7%
Results posted
Jun 2019
Primary outcomePrimary: Determine Number of Subjects With RD While on Opioid Therapy — 655; 840 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determine Number of Subjects With RD While on Opioid Therapy |
655; 840 | — |
| PRIMARY To Derive and Validate a Risk Assessment Tool to Identify Subjects at Risk of Having RD While Undergoing Opioid Therapy on the Hospital Ward |
351; 457; 458 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02811302). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.