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

Description

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 Start Date

April, 07 2017

Estimated Completion Date

March 2018

Interventions

  • Device: Capnostream Monitor

Study ID

Medtronic - MITG -- COVMOPO0560

Status

Recruiting

Trial ID

NCT02811302

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

1650

Sponsor

Medtronic - MITG

Inclusion Criteria

    1. Patients receiving parenteral opioid therapy (for post-surgical or non-surgical) pain on the hospital ward. 2. Adult age (?18 year old in US and Europe ?20 years old in Japan ?21 years old in Singapore). 3. Patient is able and willing to give informed consent.

Exclusion Criteria

    1. Expected length of stay ? 24 hours. 2. Patient is receiving intrathecal opioids. 3. Post-surgical patients with American Society of Anesthesiologists physical status (ASA PS) V or higher. 4. Patients with the status of Do Not Resuscitate (DNR), hospice, or receiving end of life therapy. 5. Ventilated or intubated patients. 6. Patient is unwilling or unable to comply fully with study procedures (including non-toleration of the capnography cannula) due to any disease condition which can raise doubt about compliance and influencing the study outcome. 7. Patient is a member of a vulnerable population, including legal incapacity or evidence that a subject cannot understand the purpose and risks of the study, regardless of authorized representative support. 8. Patient is participating in another potentially confounding drug or device clinical study.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (24)

Study Location Distance Name Phone Email
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Richard Urman MD None rurman@partners.org
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Richard Urman MD None rurman@partners.org
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Richard Urman MD None rurman@partners.org
Buffalo General Medical Center - Buffalo, New York 397.3 miles Carla Jungquist RN PhD None carlajun@buffalo.edu
Buffalo General Medical Center - Buffalo, New York 397.3 miles Carla Jungquist RN PhD None carlajun@buffalo.edu
Buffalo General Medical Center - Buffalo, New York 397.3 miles Carla Jungquist RN PhD None carlajun@buffalo.edu
Cleveland Clinic - Cleveland, Ohio 544.9 miles Ashish Khanna MD None khannaa@ccf.org
Cleveland Clinic - Cleveland, Ohio 544.9 miles Ashish Khanna MD None khannaa@ccf.org
Cleveland Clinic - Cleveland, Ohio 544.9 miles Ashish Khanna MD None khannaa@ccf.org
MetroHealth Medical Center - Cleveland, Ohio 549.6 miles Dennis Auckley MD None dauckley@metrohealth.org
MetroHealth Medical Center - Cleveland, Ohio 549.6 miles Dennis Auckley MD None dauckley@metrohealth.org
MetroHealth Medical Center - Cleveland, Ohio 549.6 miles Dennis Auckley MD None dauckley@metrohealth.org
Beaumont Hospital Royal Oak - Royal Oak, Michigan 616.2 miles Roy Soto MD None Roy.Soto@beaumont.edu
Beaumont Hospital Royal Oak - Royal Oak, Michigan 616.2 miles Roy Soto MD None Roy.Soto@beaumont.edu
Beaumont Hospital Royal Oak - Royal Oak, Michigan 616.2 miles Roy Soto MD None Roy.Soto@beaumont.edu
The Ohio State University Wexner Medical Center - Columbus, Ohio 641.8 miles Sergio Bergese MD None sergio.bergese@osumc.edu
The Ohio State University Wexner Medical Center - Columbus, Ohio 641.8 miles Sergio Bergese MD None sergio.bergese@osumc.edu
The Ohio State University Wexner Medical Center - Columbus, Ohio 641.8 miles Sergio Bergese MD None sergio.bergese@osumc.edu
Emory University Hospital - Atlanta, Georgia 932.0 miles Simon Lee MD None simon.lee@emory.edu
Emory University Hospital - Atlanta, Georgia 932.0 miles Simon Lee MD None simon.lee@emory.edu
Emory University Hospital - Atlanta, Georgia 932.0 miles Simon Lee MD None simon.lee@emory.edu
University of Colorado Hospital - Aurora, Colorado 1,759.8 miles Robert McIntyre MD None robert.mcintyre@uchsc.edu
University of Colorado Hospital - Aurora, Colorado 1,759.8 miles Robert McIntyre MD None robert.mcintyre@uchsc.edu
University of Colorado Hospital - Aurora, Colorado 1,759.8 miles Robert McIntyre MD None robert.mcintyre@uchsc.edu

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