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

Medtronic

Status: Completed

Conditions: Respiratory Depression

Treatments: Device: Capnostream Monitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT02811302

COVMOPO0560

Details and patient eligibility

About

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.

Enrollment: 1,495 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,495 participants in 1 patient group

Patients monitored by capnography

Other group

Description:

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.

Treatment:

Device: Capnostream Monitor