NCT04306211

Comparison of Oxygenation Between Nasal PAP vs Nasal During Propofol-based Sedation for EUS

Comparison of Oxygenation Between Nasal Positive Airway Pressure (PAP) Versus Standard Care During Propofol-based Sedation for Endoscopic Ultrasound in an Ambulatory Surgical Setting: a Prospective Randomized Control Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomized controlled single site study involves oxygenation, continuous positive airway pressure, and ventilation of subject via nasal mask and oxygenationvia closed facemask. The intervention of the study are delivery form of supplemental oxygen, bag-mask ventilation, and continuous nasal CPAP intraoperatively and in the post anesthesia care period.

Detailed description

124 patients with BMI\> or equal to 35kg.m2 or documented Obstructive Sleep Apnea scheduled for an EUS with Propofol sedation will be randomized to CPAP vs nasal mask for oxygenation during their procedure. Patients will be monitored every 2 minutes during the procedure and in the recovery area until discharge. If patients have difficulty or refuse to wear the mask, 2 or more simultaneous or non-synchronous adverse events, change in heart rhythm or ST changes on EKG they will immediately changed to the other group. The ansethesiologist, gastroenterologist \& patient will complete post-procedure questionnaires regarding their opinion of the oxygen delivery system.

Conditions

• Endoscopic Ultrasound

Interventions

Type	Name	Description
DEVICE	SuperNO2VA	SUPERNO2VA is nasal PAP device for oxygen delivery

Timeline

• Start date: 2020-12-14
• Primary completion: 2022-03-30
• Completion: 2022-03-30
• First posted: 2020-03-12
• Last updated: 2022-11-03
• Results posted: 2022-11-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study