COMBO Endoscopy Oropharyngeal Airway in Sedated Gastrointestinal Endoscopy for Obese Patients

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 of the COMBO Endoscopy Oropharyngeal Airway in reducing the incidence of hypoxia in obese patients undergoing gastrointestinal endoscopy under sedation.

Study Overview

• Status: Completed
• Conditions: Hypoxia; Gastric Cancer; Esophageal Cancer; Colon Cancer
• Intervention / Treatment: Device: the COMBO Endoscopy Oropharyngeal Airway

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • The First Affiliated Hospital, Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

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<28 kg/m².
• 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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of hypoxia	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	90% ≤ SpO2 < 95%	Patients will be followed for the duration of hospital stay, an expected average about 2 hours
The incidence of severe hypoxia	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	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

• Sponsor: Zhejiang University

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2025
• Primary Completion (Actual): March 26, 2025
• Study Completion (Actual): March 26, 2025

Study Registration Dates

• First Submitted: January 27, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): February 3, 2025

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Hypoxia; Obese Patients; Sedation; Gastrointestinal Endoscopy; The COMBO Endoscopy Oropharyngeal Airway
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: ZJU2025C017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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