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

Respiratory Depression Clinical Trial

— PRODIGY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02811302
• Other study ID #: COVMOPO0560
• Status: Completed
• Phase: N/A
• Start date: April 7, 2017
• Est. completion date: May 7, 2018

Study information

• Verified date: April 2019
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1495
• Est. completion date: May 7, 2018
• Est. primary completion date: May 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Respiratory Depression
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
France	Hospital Foch	Suresnes
Germany	University Hospital Bonn	Bonn
Japan	Okayama University Hospital	Okayama
Japan	The Jikei University School of Medicine Hospital	Tokyo
Netherlands	Maastricht UMC+	Maastricht	Limburg
Singapore	National University Hospital	Singapore
Spain	Hospital Clínico Universitario de Valencia	Valencia
United States	Emory University Hospital	Atlanta	Georgia
United States	University of Colorado Hospital	Aurora	Colorado
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Buffalo General Medical Center	Buffalo	New York
United States	Cleveland Clinic	Cleveland	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Providence Regional Medical Center Everett	Everett	Washington
United States	Beaumont Hospital - Royal Oak	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Countries where clinical trial is conducted

United States,  France,  Germany,  Japan,  Netherlands,  Singapore,  Spain, 

References & Publications (4)

Cashman JN, Dolin SJ. Respiratory and haemodynamic effects of acute postoperative pain management: evidence from published data. Br J Anaesth. 2004 Aug;93(2):212-23. Epub 2004 May 28. Review. — View Citation

Jarzyna D, Jungquist CR, Pasero C, Willens JS, Nisbet A, Oakes L, Dempsey SJ, Santangelo D, Polomano RC. American Society for Pain Management Nursing guidelines on monitoring for opioid-induced sedation and respiratory depression. Pain Manag Nurs. 2011 Sep;12(3):118-145.e10. doi: 10.1016/j.pmn.2011.06.008. — View Citation

Overdyk FJ, Carter R, Maddox RR, Callura J, Herrin AE, Henriquez C. Continuous oximetry/capnometry monitoring reveals frequent desaturation and bradypnea during patient-controlled analgesia. Anesth Analg. 2007 Aug;105(2):412-8. — View Citation

Sun Z, Sessler DI, Dalton JE, Devereaux PJ, Shahinyan A, Naylor AJ, Hutcherson MT, Finnegan PS, Tandon V, Darvish-Kazem S, Chugh S, Alzayer H, Kurz A. Postoperative Hypoxemia Is Common and Persistent: A Prospective Blinded Observational Study. Anesth Analg. 2015 Sep;121(3):709-15. doi: 10.1213/ANE.0000000000000836. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	48 hours
Primary	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.	48 hours