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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation
DeviceUsing the COMBO endoscopy oropharyngeal airway with High-Flow Nasal Cannula Oxygenation in sedated gastrointestinal endoscopy for morbidly obese patients
High-Flow Nasal Cannula Oxygenation
DeviceIn this group, patients use high-flow nasal cannula oxygenation
Treatment groups
Trial outcomes
Primary outcomes
The incidence of hypoxemia
75% ≤ SpO2 \< 90% for \<60 s
Secondary outcomes
The incidence of sub-clinical respiratory depression
90% ≤ SpO2 \< 95%
The incidence of severe hypoxaemia
SpO2 \< 75% or 75% ≤ SpO2 \< 90% for ≥60 s
Other outcomes
The incidence of other adverse events
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
Sponsors and contacts
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