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Completed

NCT Number: NCT06812403

Combination COMBO Endoscopy Oropharyngeal Airway With High-Flow Nasal Cannula Oxygenation in Sedated Gastrointestinal Endoscopy for Obese Patients

Hypoxia is the most common adverse event during propofol sedation for gastrointestinal endoscopy, particularly in obese patients.

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 evaluate the efficacy of the COMBO Endoscopy Oropharyngeal Airway in combination with High-Flow Nasal Cannula Oxygenation for reducing the incidence of hypoxia in obese patients undergoing gastrointestinal endoscopy under sedation.

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Key information

Conditions

Hypoxia Colonic Polyps Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Intestinal Polyps Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyp of Colon Polyps Signs and Symptoms Signs and Symptoms, Respiratory Stomach Diseases Stomach Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18≤ Age ≤70.
  • BMI ≥ 35 kg/m².
  • The ASA classification ranges from I to III.
  • 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<35 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.

Treatment and study plan

the 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 Obese Patients

Primary outcomes

  1. The incidence of hypoxia

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

    75% ≤ SpO2 < 90% for <60 s

Secondary outcomes

  1. The incidence of subclinical respiratory depression

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

    90% ≤ SpO2 < 95%

  2. The incidence of severe hypoxia

    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

Other outcomes

  1. The incidence of other adverse events

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

    Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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