NCT02811302

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,495 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Depression

Interventions

Type	Name	Description
DEVICE	Capnostream Monitor	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.

Timeline

• Start date: 2017-04-07
• Primary completion: 2018-05-07
• Completion: 2018-05-07
• First posted: 2016-06-23
• Last updated: 2019-06-12
• Results posted: 2019-06-12

Locations

16 sites across 7 countries: United States, France, Germany, Japan, Netherlands, Singapore, Spain

Regulatory

• FDA-regulated device study