Back to resultsOSA Screen Negative With Spinal Duramorph
Primary Purpose
Respiratory Depression
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Capnography monitoring
Sponsored by
About this trial
This is an interventional health services research trial for Respiratory Depression focused on measuring obstructive sleep apnea screen negative, respiratory depression, cesarean section
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Spanish speaking only
- under age 18
- contraindication to receiving drugs utilized in delivery anesthetic
Sites / Locations
- Novant Health Forsyth Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
capnography monitoring
Arm Description
single arm, all subjects receiving duramorph will receive capnography monitoring
Outcomes
Primary Outcome Measures
Respiratory Depression/Suppression
defined by values obtained utilizing capnography and pulse oximetry
Secondary Outcome Measures
Full Information
NCT ID
NCT03151226
First Posted
August 31, 2015
Last Updated
August 8, 2018
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03151226
Brief Title
OSA Screen Negative With Spinal Duramorph
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Technical difficulty and feasibility issues
Study Start Date
August 3, 2015 (Actual)
Primary Completion Date
October 1, 2015 (Actual)
Study Completion Date
October 1, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Depression
Keywords
obstructive sleep apnea screen negative, respiratory depression, cesarean section
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
capnography monitoring
Arm Type
Other
Arm Description
single arm, all subjects receiving duramorph will receive capnography monitoring
Intervention Type
Device
Intervention Name(s)
Capnography monitoring
Other Intervention Name(s)
pulse oximetry
Intervention Description
capnography and pulse oximetry will be initiated in the recovery room and worn for 12-24 hours post delivery
Primary Outcome Measure Information:
Title
Respiratory Depression/Suppression
Description
defined by values obtained utilizing capnography and pulse oximetry
Time Frame
up to 24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Spanish speaking only
under age 18
contraindication to receiving drugs utilized in delivery anesthetic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter H Pan, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novant Health Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
12. IPD Sharing Statement
Learn more about this trial
OSA Screen Negative With Spinal Duramorph
We'll reach out to this number within 24 hrs