Study of the COMBO Endoscopy Oropharyngeal Airway to Reduce Low Oxygen Levels During Sedated Gastrointestinal Endoscopy in Obese Adults

What this Trial Is About

Researchers are evaluating the COMBO Endoscopy Oropharyngeal Airway device to reduce hypoxia in obese patients undergoing gastrointestinal endoscopy with sedation using propofol. Hypoxia is a common problem during these procedures, especially among obese individuals. This trial is a multicenter, randomized, controlled clinical study led by Zhejiang University to assess the safety and effectiveness of this new device in this high-risk group. Participants are randomly assigned to one of two groups one group uses the COMBO Endoscopy Oropharyngeal Airway for oxygenation, while the other group uses a regular nasal cannula. Both devices support oxygen delivery during endoscopy and sedation. The procedure duration is limited to 45 minutes, and the study focuses on patients with a BMI of 28 kgm or higher. During the hospital stay, which averages about two hours, participants will be monitored for episodes of hypoxia and respiratory depression. Researchers will assess oxygen saturation levels and follow patients throughout the procedure and recovery period. Safety and efficacy outcomes will be recorded, including the incidence of oxygen desaturation events. The study will continue until December 2025.

COMBO Endoscopy Oropharyngeal Airway Reduces Hypoxia During Sedated Gastrointestinal Endoscopy in Obese Patients: A Multicenter, Randomized, Controlled Clinical Trial