PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY)
- Conditions
- Patients monitored by capnoGraphY
- Registration Number
- JPRN-UMIN000026993
- Lead Sponsor
- Covidien Japan Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 1650
Not provided
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, includinglegal 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Identify subjects at risk of having respiratory depression [Time Frame: 48 hours] Derive and validate a risk assessment tool to identify subjects at risk of having RD while undergoing opioid therapy on the hospital ward. Continuous respiratory monitoring using a Capnostream monitor will be included for collecting data for end tidal carbon dioxide (etCO2) and Oxygen saturation (SpO2).
- Secondary Outcome Measures
Name Time Method