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

NCT07175155 | Recruiting

• 1 other identifier: ZJU2025C140
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Gastric Cancer; Hypoxemia; Esophageal Cancer; Morbidly Obese Patients

Keywords

COMBO Endoscopy Oropharyngeal Airway; Hypoxemia; Sedation; Gastrointestinal Endoscopy; high-flow nasal cannula

Outcome Measures

Primary Outcomes (1)

• The incidence of hypoxemia

  75% ≤ SpO2 \< 90% for \<60 s

  Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Secondary Outcomes (2)

• The incidence of sub-clinical respiratory depression

  Patients will be followed for the duration of hospital stay, an expected average about 2 hours

• The incidence of severe hypoxaemia

  Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Other Outcomes (1)

• The incidence of other adverse events

  Patients will be followed for the duration of hospital stay, an expected average about 2 hours.

Study Arms (2)

COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation

EXPERIMENTAL

In this group, patients use the COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation

Device: COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation

High-Flow Nasal Cannula Oxygenation

ACTIVE COMPARATOR

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

Device: High-Flow Nasal Cannula Oxygenation

Interventions

COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation DEVICE

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

COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation

High-Flow Nasal Cannula Oxygenation DEVICE

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

High-Flow Nasal Cannula Oxygenation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (5)

Peking University First Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Jinjiang Municipal Hospital

Jinjiang, Fujian, 362200, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

The Fifth Affiliated Hospital of Wenzhou Medical University

Lishui, Zhejiang, 310000, China

RECRUITING

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Hypoxia; Esophageal Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Diansan Su, Chief Physician

CONTACT

+8618616514088; diansansu@yahoo.com

Mingxia Xu

CONTACT

+8613516713435; xumingxia@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician,Researcher

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: October 24, 2025
• Primary Completion (Estimated): August 20, 2027
• Study Completion (Estimated): August 20, 2027
• Last Updated: March 11, 2026

Record last verified: 2025-10

Locations

CN (5)