Study of COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation to Reduce Low Oxygen Levels during Sedated Gastrointestinal Endoscopy in Morbidly Obese Adults

What this Trial Is About

Researchers are studying morbidly obese patients, defined as those with a body mass index BMI of 35 or higher, undergoing sedated gastrointestinal endoscopy. The study aims to find out if using a combination of the COMBO Endoscopy Oropharyngeal Airway device and High-Flow Nasal Cannula oxygenation can reduce episodes of low oxygen levels hypoxemia during these procedures, a common issue exceeding 40% in this group. Participants are randomly assigned to one of two groups one group receives oxygen through the High-Flow Nasal Cannula along with the COMBO Endoscopy Oropharyngeal Airway device, which also supports airway management and monitoring the other group receives only the High-Flow Nasal Cannula oxygenation. The procedure duration is expected to be no longer than 45 minutes. This is a multicenter, randomized, controlled trial sponsored by Zhejiang University. During the hospital stay, typically around 2 hours, patients will be monitored for occurrences of hypoxemia and related respiratory issues such as sub-clinical respiratory depression and severe hypoxemia. The study tracks these outcomes throughout the procedure and recovery period to evaluate the effectiveness of the combination device and oxygen support. Safety and any adverse events will also be monitored closely during this time.

Combination of COMBO Endoscopy Oropharyngeal Airway and HFNC Oxygenation in Sedated Gastrointestinal Endoscopy for Morbidly Obese Patients