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PRediction of Opioid-induced Respiratory Depression In Patients Monitored by capnoGraphY — PRODIGY  

Respiratory Depression Clinical Trial

Official title:
PRediction of Opioid-induced Respiratory Depression In Patients Monitored by capnoGraphY (PRODIGY)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02811302
Study type Interventional
Source Medtronic - MITG
Contact
Status Completed
Phase N/A
Start date April 7, 2017
Completion date May 7, 2018
View Details
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