The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway in Gastrointestinal Endoscopy Procedure

June 19, 2025 updated by: diansan su, RenJi Hospital

The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway Reduce the Incidence of Hypoxia in Patients Undergoing Gastrointestinal Endoscopy Sedated With Propofol.

Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing gastrointestinal endoscopy with propofol. 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 our randomized study is to assess the efficacy and safety of the COMBO Endoscopy Oropharyngeal Airway reduce the incidence of hypoxia on patients undergoing gastrointestinal endoscopy under propofol sedation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • The First Affiliated Hospital with Nanjing Medical University
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recruiting
        • The First Affiliated Hospital of NanChang University
        • Contact:
          • Shibiao Chen, Dr
          • Phone Number: 13870982918
    • Shandong
      • Jinan, Shandong, China, 250014
        • Recruiting
        • Shangdong Provincial Qianfoshan Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
      • Shanghai, Shanghai, China, 200127
      • Shanghai, Shanghai, China
        • Recruiting
        • Tongji Hospital of Tongji University
        • Contact:
    • Shanxi
      • Xi'an, Shanxi, China, 710061
        • Recruiting
        • The First Affliated Hospital of Xi'an Jiangtong University
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Recruiting
        • Tianjin Mediacal University General Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • the First Affliated Hospital, Zhejiang University School of Medicine
        • Contact:
    • shanghia
      • Shanghai, shanghia, China
        • Recruiting
        • Xinhua Hospital Affliated To Shanghai Jiaotong University School Of Medicine
        • Contact:
          • Lai Jiang, Dr
          • Phone Number: 13651695976

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18≤ Age ≤60.
  • Patients undergoing gastroendoscopy and/or colonoscopy procedure.
  • Patients have signed the informed consent form.
  • The ASA classification ranges from I to II.
  • The estimated duration of the procedure does not exceed 45 minutes.

Exclusion Criteria:

  • Patients who exhibit contraindications to oropharyngeal airway ventilation, such as coagulation disorders, a predisposition to oral and nasal bleeding, mucosal damage, or anatomical constraints impeding oropharyngeal channel placement.
  • Severe cardiac insufficiency, defined as a maximal exercise capacity of less than 4 metabolic equivalents (METs).
  • Profound renal insufficiency necessitating preoperative dialysis.
  • A confirmed severe liver dysfunction.
  • Patients diagnosed with chronic obstructive pulmonary disease (COPD) or those presently experiencing other acute and chronic pulmonary conditions necessitating prolonged or intermittent oxygen therapy.
  • Elevated intracranial pressure.
  • Upper respiratory tract infections, encompassing the oral, nasal, and pharyngeal regions.
  • Fever, defined as a core body temperature exceeding 37.5 degrees Celsius.
  • Pregnancy or lactation.
  • Hypersensitivity reactions to sedatives like propofol or medical equipment such as adhesive tape.
  • Urgent surgical intervention.
  • Polytrauma.
  • Peripheral oxygen saturation (SpO2) levels below 95% while breathing room air preoperatively.
  • BMI<18.5 or BMI>30.
  • Patients with a documented history of substance abuse, specifically drugs and/or alcohol, within the two years preceding the commencement of the screening period. Substance abuse in this context is defined as consuming more than three standard alcoholic beverages daily, roughly equivalent to 10g of alcohol or 50g of Chinese Baijiu.
  • Patients with a history of mental and neurological disorders, including but not limited to depression, severe central nervous system depression, Parkinson's disease, basal ganglia lesions, schizophrenia, epilepsy, Alzheimer's disease, and myasthenia gravis.
  • Presently engaged in concurrent participation in additional clinical trials.
  • Patients considered ineligible by researchers for inclusion in this clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the COMBO Endoscopy Oropharyngeal Airway Group
In this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
Device: the COMBO Endoscopy Oropharyngeal Airway
Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
Active Comparator: Regular Nasal Cannula Group
In this group, patients use the regular nasal cannula for oxygenation.
Device: Regular Nasal Cannula
Using regular nasal cannula for oxygenation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of hypoxia
Time Frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
(75% ≤ SpO2 < 90% for <60 s)
Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of sub-clinical respiratory depression
Time Frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
(90% ≤ SpO2 < 95%)
Patients will be followed for the duration of hospital stay, an expected average about 2 hours
The incidence of severe hypoxia
Time Frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
(SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s)
Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of other adverse events
Time Frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Collaborators

The First Affiliated Hospital with Nanjing Medical University
Fudan University
First Affiliated Hospital Xi'an Jiaotong University
Qianfoshan Hospital
Tianjin Medical University General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2023

Primary Completion (Estimated)

December 27, 2025

Study Completion (Estimated)

December 27, 2025

Study Registration Dates

First Submitted

September 19, 2023

First Submitted That Met QC Criteria

October 7, 2023

First Posted (Actual)

October 13, 2023

Study Record Updates

Last Update Posted (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 19, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LY2023-159-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified participant data (including data dictionaries) and analysis codes generated in this study are available upon reasonable request. Additional documents, such as the study protocol and statistical analysis plan, can also be provided. Data will be accessible beginning 3 months after article publication for at least 5 years. Researchers seeking access must submit a request to the corresponding author for approval, which will be granted based on scientific merit and compliance with a data sharing agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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