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

Status:	Completed
Conditions:	Depression, Depression, Pulmonary
Therapuetic Areas:	Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	6/13/2018
Start Date:	April 7, 2017
End Date:	May 7, 2018

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

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.

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.

We found this trial at

sites

University of Colorado Hospital

12605 East 16th Avenue
Aurora, Colorado 80045

720-848-0000