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
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Peking University First Hospital
RECRUITING
Beijing
The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Jinjiang Municipal Hospital
RECRUITING
Jinjiang
The Fifth Affiliated Hospital of Wenzhou Medical University
RECRUITING
Lishui
Taizhou Hospital of Zhejiang Province
RECRUITING
Taizhou
Contact Information
Primary
Diansan Su, Chief Physician
diansansu@yahoo.com
+8618616514088
Backup
Mingxia Xu
xumingxia@zju.edu.cn
+8613516713435
Time Frame
Start Date:2025-10-24
Estimated Completion Date:2027-08-20
Participants
Target number of participants:410
Treatments
Experimental: COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation
In this group, patients use the COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation