Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07175155

Recruiting nowNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionHypoxemia, Esophageal Cancer, Morbidly Obese Patients, Gastric Cancer

Full registry criteria

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 and study arms

COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation

Device

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

High-Flow Nasal Cannula Oxygenation

Device

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

Primary outcomes

The incidence of hypoxemiaPatients will be followed for the duration of hospital stay, an expected average about 2 hours

75% ≤ SpO2 \< 90% for \<60 s

Study locations

5 locations were listed when this page was built. The first 40 are shown.

Peking University First Hospital🇨🇳 Beijing, Beijing Municipality, China
Dongxin Wang, DrContact
The First Affiliated Hospital, Zhejiang University School of Medicine🇨🇳 Hangzhou, Zhejiang, China
Diansan Su, DrContact
Jinjiang Municipal Hospital🇨🇳 Jinjiang, Fujian, China
Fusheng Xu, DrContact
The Fifth Affiliated Hospital of Wenzhou Medical University🇨🇳 Lishui, Zhejiang, China
Zhilan DouContact
Taizhou Hospital of Zhejiang Province🇨🇳 Taizhou, Zhejiang, China
Lijun ZhuContact