Study Stopped
Technical difficulty and feasibility issues
OSA Screen Negative With Spinal Duramorph
A Prospective, Observational, Double-blind (Black-Box) Study Evaluating Incidence, Severity and Predictive Factors of Respiratory Depression and Sleep Disorder Pattern During Postoperative Neuraxial Opioid Analgesia in OSA Screened Negative With BMI>=35 Kg/m2 Obstetric Patients After Cesarean Delivery Using Current Standard Intermittent Postoperative Monitoring Compared to Continuous Pulse Oximetry/Capnography
1 other identifier
interventional
3
1 country
1
Brief Summary
Non emergent scheduled cesarean sections will be consented to participate in this study of patients who have screened negative for obstructive sleep apnea and who are also BMI\>/= 35 to have capnography monitoring postoperatively. The capnography and pulse oximetry will be initiated in the post anesthesia care unit and be worn for 12-24 hours after delivery. Data will be retrieved after that time period in a deidentified fashion. Medication usage will be reviewed as well as the standard of care information from the duramorph monitoring will be retrieved.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 3, 2015
CompletedFirst Submitted
Initial submission to the registry
August 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFirst Posted
Study publicly available on registry
May 12, 2017
CompletedResults Posted
Study results publicly available
March 8, 2018
CompletedSeptember 7, 2018
August 1, 2018
2 months
August 31, 2015
February 7, 2018
August 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Respiratory Depression/Suppression
defined by values obtained utilizing capnography and pulse oximetry
up to 24 hours
Study Arms (1)
capnography monitoring
OTHERsingle arm, all subjects receiving duramorph will receive capnography monitoring
Interventions
capnography and pulse oximetry will be initiated in the recovery room and worn for 12-24 hours post delivery
Eligibility Criteria
You may qualify if:
- OSA screen negative per hospital protocol
- age 18 or greater
- BMI\>35
- consent to participate to wear capnography and pulse oximetry monitoring devices post delivery
You may not qualify if:
- Spanish speaking only
- under age 18
- contraindication to receiving drugs utilized in delivery anesthetic
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Peter H. Pan
- Organization
- Wake Forest School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Peter H Pan, MD
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2015
First Posted
May 12, 2017
Study Start
August 3, 2015
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
September 7, 2018
Results First Posted
March 8, 2018
Record last verified: 2018-08