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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang University

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

Treatment groups

410 Participants
are divided into 2 treatment groups

Sponsors and collaborators