NCT03151226

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Depression

Interventions

Type	Name	Description
DEVICE	Capnography monitoring	capnography and pulse oximetry will be initiated in the recovery room and worn for 12-24 hours post delivery

Timeline

• Start date: 2015-08-03
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2017-05-12
• Last updated: 2018-09-07
• Results posted: 2018-03-08

Locations

1 site across 1 country: United States