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

NCT02811302 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1495

Last updated 2019-06-12

Study results available
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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

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.

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • Frank J Overdyk · Roper St. Francis Healthcare

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-07
Primary Completion
2018-05-07
Completion
2018-05-07
FDA Device
Yes

Countries

  • United States
  • France
  • Germany
  • Japan
  • Netherlands
  • Singapore
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02811302 on ClinicalTrials.gov