About this trial
Hypoxaemia during sedated gastrointestinal endoscopy exceeds 40 % in morbidly obese (BMI ≥ 35 kg m-²) patients. High-flow nasal cannula alone often fails because of persistent airway collapse. A recent innovation in this domain is the COMBO Endoscopy Oropharyngeal Airway-a multifaceted device that encompasses capnography monitoring, bite block , oxygenation support, and oropharyngeal airway management.The purpose of this study is to investigate whether the combination of the COMBO Endoscopy Oropharyngeal Airway and High-Flow Nasal Cannula oxygenation reduces the incidence of hypoxemia in this population.
Eligibility criteria
Qualifiers
Age ≥ 18 years.
BMI ≥ 35 kg/m².
Patients undergoing gastroscopy or gastrointestinal endoscopy.
The estimated duration of the procedure does not exceed 45 minutes.
Disqualifiers
Coagulation disorders or bleeding tendency (e.g., oral/nasal bleeding risk, mucosal injury, oropharyngeal obstruction) making oropharyngeal airway placement unsafe or unfeasible.
Active upper respiratory tract infection (oral, nasal, or pharyngeal), or fever (core temperature >37.5°C).
Chronic obstructive pulmonary disease or other acute/chronic pulmonary diseases requiring long-term or intermittent oxygen therapy, or preoperative SpO₂ ≤ 92% on room air.
Severe organ dysfunction, including: Cardiac insufficiency (<4 METs), Severe renal insufficiency (requiring dialysis), Diagnosed severe hepatic insufficiency, Increased intracranial pressure, ASA physical status ≥ IV.
Trial design
Treatments tested in this trial
- COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation
- High-Flow Nasal Cannula Oxygenation