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Completed Not applicable Interventional Results available

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

ClinicalTrials.gov ID: NCT02811302

Public ClinicalTrials.gov record NCT02811302. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 2:27 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT02811302
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Medtronic - MITG
Industry
Enrollment
1,495 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 6, 2017
Primary completion
May 6, 2018
Completion
May 6, 2018
Last update posted
Jun 11, 2019

2017 – 2018

United States locations

U.S. sites
9
U.S. states
7
U.S. cities
8
Facility City State ZIP Site status
University of Colorado Hospital Aurora Colorado 80045
Emory University Hospital Atlanta Georgia 30322
Brigham and Women's Hospital Boston Massachusetts 02115
Beaumont Hospital - Royal Oak Royal Oak Michigan 48073
Buffalo General Medical Center Buffalo New York 14203
MetroHealth Medical Center Cleveland Ohio 44109
Cleveland Clinic Cleveland Ohio 44195
The Ohio State University Wexner Medical Center Columbus Ohio 43210
Providence Regional Medical Center Everett Everett Washington 98201-1689

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02811302, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 11, 2019 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02811302 live on ClinicalTrials.gov.

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