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

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ClinicalTrials.gov Identifier: NCT02811302
Recruitment Status : Completed
First Posted : June 23, 2016
Results First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1495 participants
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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).

  2. 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
Criteria

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.

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Medtronic - MITG
Investigators
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Study Chair: Frank J Overdyk Roper St. Francis Healthcare
  Study Documents (Full-Text)

Documents provided by Medtronic - MITG:
Study Protocol  [PDF] November 29, 2016
Statistical Analysis Plan  [PDF] September 18, 2017


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT02811302     History of Changes
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases