PRediction of Opioid-induced Respiratory Depression In Patients Monitored by capnoGraphY (PRODIGY)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02811302 |
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Recruitment Status :
Completed
First Posted : June 23, 2016
Results First Posted : June 12, 2019
Last Update Posted : June 12, 2019
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Respiratory Depression | Device: Capnostream Monitor | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1495 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Screening |
| Official Title: | PRediction of Opioid-induced Respiratory Depression In Patients Monitored by capnoGraphY (PRODIGY) |
| Actual Study Start Date : | April 7, 2017 |
| Actual Primary Completion Date : | May 7, 2018 |
| Actual Study Completion Date : | May 7, 2018 |
| Arm | Intervention/treatment |
|---|---|
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Patients monitored by capnography
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.
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Device: Capnostream Monitor
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. |
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811302
| United States, Colorado | |
| University of Colorado Hospital | |
| Aurora, Colorado, United States, 80045 | |
| United States, Georgia | |
| Emory University Hospital | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Beaumont Hospital - Royal Oak | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, New York | |
| Buffalo General Medical Center | |
| Buffalo, New York, United States, 14203 | |
| United States, Ohio | |
| MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| The Ohio State University Wexner Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| United States, Washington | |
| Providence Regional Medical Center Everett | |
| Everett, Washington, United States, 98201-1689 | |
| France | |
| Hospital Foch | |
| Suresnes, France, 92151 | |
| Germany | |
| University Hospital Bonn | |
| Bonn, Germany, 53127 | |
| Japan | |
| Okayama University Hospital | |
| Okayama, Japan, 700-8558 | |
| The Jikei University School of Medicine Hospital | |
| Tokyo, Japan, 105-8471 | |
| Netherlands | |
| Maastricht UMC+ | |
| Maastricht, Limburg, Netherlands, 6229 HX | |
| Singapore | |
| National University Hospital | |
| Singapore, Singapore, 119074 | |
| Spain | |
| Hospital Clínico Universitario de Valencia | |
| Valencia, Spain, 46010 | |
| Study Chair: | Frank J Overdyk | Roper St. Francis Healthcare |
Documents provided by Medtronic - MITG:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Medtronic - MITG |
| ClinicalTrials.gov Identifier: | NCT02811302 |
| Other Study ID Numbers: |
COVMOPO0560 |
| First Posted: | June 23, 2016 Key Record Dates |
| Results First Posted: | June 12, 2019 |
| Last Update Posted: | June 12, 2019 |
| Last Verified: | April 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Product Manufactured in and Exported from the U.S.: | No |
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Respiratory Insufficiency Depression Depressive Disorder Behavioral Symptoms |
Mood Disorders Mental Disorders Respiration Disorders Respiratory Tract Diseases |