CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,495 enrolled
Drug / intervention
Capnostream Monitordevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02811302
NCT02811302N/ACompleted
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PRediction of Opioid-induced Respiratory Depression In Patients Monitored by capnoGraphY (PRODIGY)

Medtronic - MITG·interventional·Posted Jun 23, 2016·Updated Jun 12, 2019

In Brief

A clinical study evaluating Capnostream Monitor for Respiratory Depression. Completed, enrolled 1,495 participants across 16 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Depression
CountriesFrance, Germany, Japan, Netherlands, Singapore, Spain, United States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 23, 2016
Enrollment StartApr 7, 2017
Primary CompletionMay 7, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 10.0 years ago

Interventions

Capnostream Monitordevice

Capnography and pulse oximetry monitoring data will be collected for up to 48 hours while patients are on the hospital ward. In addition, a 1-month follow up will be completed.