Using a new airway device with high-flow oxygen for obese patients during gastrointestinal endoscopy

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

This study is testing a new airway device with high-flow oxygen to see if it helps obese patients breathe better during gastrointestinal endoscopy procedures.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Zhejiang University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06812403 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the COMBO Endoscopy Oropharyngeal Airway combined with High-Flow Nasal Cannula Oxygenation to reduce hypoxia in obese patients undergoing gastrointestinal endoscopy under sedation. Hypoxia is a common complication during these procedures, particularly in patients with obesity. The COMBO device is designed to enhance airway management and oxygenation support, aiming to improve patient safety and outcomes during endoscopic procedures. The study will involve patients aged 18 to 70 with a BMI of 35 or higher, focusing on those undergoing gastroendoscopy and colonoscopy.

Who should consider this trial

Good fit: Ideal candidates are obese patients aged 18 to 70 with a BMI of 35 or higher undergoing gastroendoscopy or colonoscopy.

Not a fit: Patients with severe cardiac, renal, or liver dysfunction, or those with contraindications to oropharyngeal airway ventilation will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of hypoxia in obese patients during gastrointestinal endoscopy.

How similar studies have performed: While the specific combination of devices used in this study may be novel, similar approaches in managing hypoxia during sedation have shown promise in other studies.

Eligibility criteria

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.

Where this trial is running

Hangzhou, Zhejiang

• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Diansan Su, Dr

Conditions Hypoxia; Esophageal Cancer; Gastric Cancer; Polyp of Colon; The COMBO Endoscopy Oropharyngeal Airway; High-flow nasal cannula Oxygenation; sedation; Gastrointestinal endoscopes