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Recruiting NCT07175155

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

No phase Interventional Hypoxemia Esophageal Cancer Morbidly Obese Patients Gastric Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: COMBO Endoscopy Oropharyngeal Airway with High-Flow Nasal Cannula Oxygenation, High-Flow Nasal Cannula Oxygenation.
Who it may be relevant to
Registry conditions: Hypoxemia, Esophageal Cancer, Morbidly Obese Patients, Gastric Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Combination of COMBO Endoscopy Oropharyngeal Airway and High-flow Nasal Cannula Oxygenation in Sedated Gastrointestinal Endoscopy for Morbidly Obese Patients: a Multicenter, Randomized, Controlled Clinical Trial

Overview

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.

Interventions

  • Device 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
  • Device High-Flow Nasal Cannula Oxygenation
    In this group, patients use high-flow nasal cannula oxygenation

Primary outcome measures

  • The incidence of hypoxemia [Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
Secondary outcome measures (2)
  • 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]
  • The incidence of severe hypoxaemia [Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

China · 5 centers
  • Peking University First Hospital — Beijing
  • Jinjiang Municipal Hospital — Jinjiang
  • The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
  • The Fifth Affiliated Hospital of Wenzhou Medical University — Lishui
  • Taizhou Hospital of Zhejiang Province — Taizhou

Identifiers

NCT: NCT07175155 · ZJU2025C140

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗