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

Sponsor
Zhejiang University
Study ID
NCT07175155
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
Sep 16, 2025
Start date
Oct 24, 2025
Status verified
Oct 2025
Primary completion
Aug 20, 2027
Completion
Aug 20, 2027

Study Design

Enrollment
410 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 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
  • Active Comparator: High-Flow Nasal Cannula Oxygenation
    In this group, patients use the High-Flow Nasal Cannula Oxygenation

Primary Outcome Measure

The incidence of hypoxemia [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours ]

Central Contacts

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