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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
1,495
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.
University of Colorado Hospital
Aurora, Colorado, United States
Emory University Hospital
Atlanta, Georgia, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States
Buffalo General Medical Center
Buffalo, New York, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Providence Regional Medical Center Everett
Everett, Washington, United States
Hospital Foch
Suresnes, France
...and 6 more locations
Determine Number of Subjects With RD While on Opioid Therapy
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).
Time frame: 48 hours
To Derive and Validate a Risk Assessment Tool to Identify Subjects at Risk of Having RD While Undergoing Opioid Therapy on the Hospital Ward
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.
Time frame: 48 hours
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