Evaluating the COMBO Endoscopy Oropharyngeal Airway for Preventing Low Oxygen During Sedated ERCP Procedures in Adults

What this Trial Is About

This research aims to evaluate the use of the COMBO Endoscopy Oropharyngeal Airway device to reduce the occurrence of low oxygen levels hypoxia during sedation for patients undergoing Endoscopic Retrograde Cholangiopancreatography ERCP. The study targets patients with conditions such as choledocholithiasis with cholecystitis with obstruction, obstructive jaundice, pancreatitis, and cholelithiasis. It is conducted under phase 2 clinical trial conditions to explore this new devices role in improving patient safety during the procedure. Participants will use the COMBO Endoscopy Oropharyngeal Airway, a multifunctional device designed to provide oxygen support, protect the airways, and monitor breathing during sedated ERCP procedures. The device integrates capnography monitoring, bite block protection, oxygen delivery, and airway management tailored specifically for endoscopic procedures. This device group represents the experimental arm of the study. During the hospital stay, expected to last about 2 hours, patients will be closely monitored to measure the frequency of hypoxia, sub-clinical respiratory depression, and severe hypoxia. Researchers will observe and record these breathing-related outcomes throughout the procedure and recovery. The study includes safety evaluations and continuous monitoring to assess the devices impact on patient oxygen levels during sedation.

COMBO Endoscopy Oropharyngeal Airway in Sedated Endoscopic Retrograde Cholangiopancreatography for Patients