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

Zhejiang University

Status: Enrolling

Conditions: Gastric Cancer; Morbidly Obese Patients; Esophageal Cancer; Hypoxemia

Treatments: Device: COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation; Device: High-Flow Nasal Cannula Oxygenation

Study type: Interventional

Funder types: Other

Identifiers

NCT07175155

ZJU2025C140

Details and patient eligibility

About

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.

Enrollment: 410 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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410 participants in 2 patient groups

COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation

Experimental group

Description:

In this group, patients use the COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation

Treatment:

Device: COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation

High-Flow Nasal Cannula Oxygenation

Active Comparator group

Description:

In this group, patients use the High-Flow Nasal Cannula Oxygenation

Treatment:

Device: High-Flow Nasal Cannula Oxygenation