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

Locations

5
Peking University First Hospital100000, BeijingBeijing Municipality, China
Jinjiang Municipal Hospital362200, JinjiangFujian, China
The First Affiliated Hospital, Zhejiang University School of Medicine310000, HangzhouZhejiang, China
The Fifth Affiliated Hospital of Wenzhou Medical University310000, LishuiZhejiang, China

Sponsors and collaborators

Zhejiang University

Lead sponsor