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NCT02811302 · ClinicalTrials.gov registry record · NA
PRediction of Opioid-induced Respiratory Depression In Patients Monitored by capnoGraphY
A NA study, sponsored by Medtronic - MITG.
- Completed
- Registry status
- NA
- Development phase
- 1,495
- Enrollment target
NCT02811302: Completed NA study, sponsored by Medtronic - MITG.
NCT02811302 is a NA study that has completed, run by Medtronic - MITG. The registered enrollment target is 1,495 participants, roughly in line with the 1,404-participant average among 58,714 other NA trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02811302, a NA study, has completed, sponsored by Medtronic - MITG.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,495 participants
- Enrollment target
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.
Primary Outcome
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 (rORAD
Interventions
- DEVICE Capnostream Monitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,495 participants |
| Start Date | 2017-04-07 |
| Est. Completion | 2018-05-07 |
| Phase | NA |
What the finished NCT02811302 record still lists
NCT02811302 is an interventional study that assigns participants to a tested intervention. Its 1,495 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 1,404-participant average among 58,714 other NA trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Capnostream Monitor is the first listed.
NCT02811302 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02811302 about?
NCT02811302 is a clinical study titled "PRediction of Opioid-induced Respiratory Depression In Patients Monitored by capnoGraphY". 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....
What is the current status of trial NCT02811302?
This trial is currently completed. It is a NA study. The enrollment target is 1,495 participants. The study started on 2017-04-07. Estimated completion is 2018-05-07.
What interventions are being tested in trial NCT02811302?
The interventions under investigation include: Capnostream Monitor (DEVICE).
Who is sponsoring clinical trial NCT02811302?
This trial is sponsored by Medtronic - MITG, which has 119 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02811302's enrollment target sits among peer trials
1,495 68th of 2000 higher than 1,933 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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