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

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.

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Key information

Conditions

Respiratory Depression Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Foch, Suresnes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Expected length of stay ≤ 24 hours.
Patient is receiving intrathecal opioids.
Post-surgical patients with American Society of Anesthesiologists physical status (ASA PS) V or higher.
Patients with the status of Do Not Resuscitate (DNR), hospice, or receiving end of life therapy.
Ventilated or intubated patients.
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.
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.
Patient is participating in another potentially confounding drug or device clinical study.

Treatment and study plan

Capnostream Monitor

Device

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.

Primary outcomes

Determine Number of Subjects With RD While on Opioid Therapy

Time frame: 48 hours
Continuous respiratory monitoring using a Capnostream monitor will be included for collecting data for end tidal carbon dioxide (etCO2) and Oxygen saturation (SpO2). Positive RD determination was provided by an independent Clinical Event Committee, by assessing the following parameters:
- etCO2 ≤ 15 or ≥ 60 mmHg for ≥ 3 minutes, or
- RR ≤ 5 breaths for ≥ 3 minutes, or
- SpO2 ≤ 85% for ≥ 3 minutes, or
- Apnea episode lasting > 30 seconds, or
- Any respiratory Opioid-Related Adverse Event (rORADE).
To Derive and Validate a Risk Assessment Tool to Identify Subjects at Risk of Having RD While Undergoing Opioid Therapy on the Hospital Ward

Time frame: 48 hours

A risk assessment tool will be derived and validated using the incidence of RD episodes captured by continuous capnography and pulse oximetry measurements recorded on the Capnostream device memory data in conjunction with the clinical data as reported by the investigator.

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

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

Acronym: PRODIGY

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Jun 23, 2016
Registry last updated: Jun 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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