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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

Inclusion Criteria:

  • Age ≥ 18 years.
  • BMI ≥ 35 kg/m².
  • Patients undergoing gastroscopy or gastrointestinal endoscopy.
  • The estimated duration of the procedure does not exceed 45 minutes.
  • Patients have signed the informed consent form.

Exclusion Criteria:

  • 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.
  • Confirmed pregnancy or current breastfeeding.
  • Known allergy to sedatives (e.g., propofol) or medical adhesives.
  • Multiple traumatic injuries.
  • Current participation in another clinical trial.
  • Other conditions deemed unsuitable by the investigator.

Study details
    Hypoxemia
    Esophageal Cancer
    Morbidly Obese Patients
    Gastric Cancer

NCT07175155

Zhejiang University

31 January 2026

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