OSA Screen Negative With Spinal Duramorph

Respiratory Depression Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03151226
• Other study ID #: IRB00033095
• Status: Terminated
• Phase: N/A
• Start date: August 3, 2015
• Est. completion date: October 1, 2015

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: October 1, 2015
• Est. primary completion date: October 1, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Respiratory Depression
• Respiratory Insufficiency

Intervention

Device:
• Capnography monitoring
capnography and pulse oximetry will be initiated in the recovery room and worn for 12-24 hours post delivery

Locations

Country	Name	City	State
United States	Novant Health Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory Depression/Suppression	defined by values obtained utilizing capnography and pulse oximetry	up to 24 hours