COMBO Endoscopy Oropharyngeal Airway Reduces Hypoxia During Sedated Gastrointestinal Endoscopy in Obese Patients: A Multicenter, Randomized, Controlled Clinical Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing gastrointestinal endoscopy with propofol. This is particularly true for obese patients, who have a higher incidence of hypoxia. 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. This device has been purposefully designed to cater to the unique requirements of endoscopic procedures. The principal objective of this study is to assess the efficacy and safety of the COMBO Endoscopy Oropharyngeal Airway in reducing the incidence of hypoxia in obese patients undergoing gastrointestinal endoscopy under sedation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Age 18≤ Age ≤70.

• BMI ≥ 28 kg/m².

• The ASA classification ranges from I to II.

• Patients have signed the informed consent form.

• Patients undergoing gastroendoscopy and colonoscopy procedure.

• The estimated duration of the procedure does not exceed 45 minutes.

Locations
Other Locations
China
The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
The Fourth Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Zhejiang Cancer hospital
RECRUITING
Hangzhou
Contact Information
Primary
Diansan Su, Chief Physician
diansansu@yahoo.com
+8618616514088
Backup
Mingxia Xu
xumingxia@zju.edu.cn
+8613516713435
Time Frame
Start Date: 2025-04-11
Estimated Completion Date: 2025-12-04
Participants
Target number of participants: 580
Treatments
Experimental: the COMBO Endoscopy Oropharyngeal Airway Group
In this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
Active_comparator: Regular Nasal Cannula Group
In this group, patients use the regular nasal cannula for oxygenation.
Sponsors
Leads: Zhejiang University

This content was sourced from clinicaltrials.gov