MedTrace Logo

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

NCT06796764 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 580

Last updated 2025-09-10

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

the COMBO Endoscopy Oropharyngeal Airway Group

Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.

DEVICE

Regular Nasal Cannula

Using regular nasal cannula for oxygenation.

Sponsors & Collaborators

  • Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-11
Primary Completion
2025-12-04
Completion
2025-12-04

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06796764 on ClinicalTrials.gov