Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGINTERVENTIONAL

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

Combination of COMBO Endoscopy Oropharyngeal Airway and High-flow Nasal Cannula Oxygenation in Sedated Gastrointestinal Endoscopy for Morbidly Obese Patients: a Multicenter, Randomized, Controlled Clinical Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form form. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation

Using the COMBO endoscopy oropharyngeal airway with High-Flow Nasal Cannula Oxygenation in sedated gastrointestinal endoscopy for morbidly obese patients

DEVICE

High-Flow Nasal Cannula Oxygenation

In this group, patients use high-flow nasal cannula oxygenation

Locations (5)

Peking University First Hospital
Beijing, Beijing Municipality, China
Jinjiang Municipal Hospital
Jinjiang, Fujian, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Fifth Affiliated Hospital of Wenzhou Medical University
Lishui, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China