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Recruiting NCT06796764

COMBO Endoscopy Oropharyngeal Airway Reduces Hypoxia During Sedated Gastrointestinal Endoscopy in Obese Patients: A Multicenter, Randomized, Controlled Clinical Trial

No phase Interventional Hypoxia Esophageal Cancer 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: the COMBO Endoscopy Oropharyngeal Airway Group, Regular Nasal Cannula.
Who it may be relevant to
Registry conditions: Hypoxia, Esophageal Cancer, Gastric Cancer. Basic parameters: 18 years — 70 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 →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Device the COMBO Endoscopy Oropharyngeal Airway Group
    Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
  • Device Regular Nasal Cannula
    Using regular nasal cannula for oxygenation.

Primary outcome measures

  • The incidence of hypoxia [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]
  • SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s [Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]

Eligibility criteria

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.

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
Open label
Primary purpose
Prevention

Study locations

China · 3 centers
  • The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
  • The Fourth Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
  • Zhejiang Cancer hospital — Hangzhou

Identifiers

NCT: NCT06796764 · ZJU2025B0065

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗