Combination of COMBO Endoscopy Oropharyngeal Airway and HFNC Oxygenation in Sedated Gastrointestinal Endoscopy for Morbidly Obese Patients

NCT ID: NCT07175155

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

410 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-24

Study Completion Date

2027-08-20

Brief Summary

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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.

Detailed Description

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Conditions

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Hypoxemia Esophageal Cancer Morbidly Obese Patients Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation

Intervention Type DEVICE

Using the COMBO endoscopy oropharyngeal airway with High-Flow Nasal Cannula Oxygenation in sedated gastrointestinal endoscopy for morbidly obese patients

High-Flow Nasal Cannula Oxygenation

In this group, patients use the High-Flow Nasal Cannula Oxygenation

Group Type ACTIVE_COMPARATOR

High-Flow Nasal Cannula Oxygenation

Intervention Type DEVICE

In this group, patients use high-flow nasal cannula oxygenation

Interventions

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COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation

Using the COMBO endoscopy oropharyngeal airway with High-Flow Nasal Cannula Oxygenation in sedated gastrointestinal endoscopy for morbidly obese patients

Intervention Type DEVICE

High-Flow Nasal Cannula Oxygenation

In this group, patients use high-flow nasal cannula oxygenation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Coagulation disorders or bleeding tendency (e.g., oral/nasal bleeding risk, mucosal injury, oropharyngeal obstruction) making oropharyngeal airway placement unsafe or unfeasible.
* Active upper respiratory tract infection (oral, nasal, or pharyngeal), or fever (core temperature \>37.5°C).
* Chronic obstructive pulmonary disease or other acute/chronic pulmonary diseases requiring long-term or intermittent oxygen therapy, or preoperative SpO₂ ≤ 92% on room air.
* Severe organ dysfunction, including: Cardiac insufficiency (\<4 METs), Severe renal insufficiency (requiring dialysis), Diagnosed severe hepatic insufficiency, Increased intracranial pressure, ASA physical status ≥ IV.
* Confirmed pregnancy or current breastfeeding.
* Known allergy to sedatives (e.g., propofol) or medical adhesives.
* Multiple traumatic injuries.
* Current participation in another clinical trial.
* Other conditions deemed unsuitable by the investigator.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Diansan Su

Chief Physician,Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

The Fifth Affiliated Hospital of Wenzhou Medical University

Lishui, Zhejiang, China

Site Status NOT_YET_RECRUITING

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Diansan Su, Chief Physician

Role: CONTACT

+8618616514088

Mingxia Xu

Role: CONTACT

+8613516713435

Facility Contacts

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Dongxin Wang, Dr

Role: primary

Diansan Su, Dr

Role: primary

+8618616514088

Zhilan Dou

Role: primary

+8618857809608

Wei Yan

Role: primary

+8613284040207

Other Identifiers

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ZJU2025C140

Identifier Type: -

Identifier Source: org_study_id

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