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

Launched by ZHEJIANG UNIVERSITY · Jan 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the COMBO Endoscopy Oropharyngeal Airway, which aims to help prevent low oxygen levels (hypoxia) in obese patients during gastrointestinal endoscopy procedures, such as examining the stomach or colon while they are sedated. Hypoxia can be a common problem, especially for people with obesity, and this innovative device is designed to support breathing and monitor oxygen levels throughout the procedure. The trial will assess how effective and safe this device is for reducing hypoxia in patients who meet specific criteria.

To be eligible for the trial, participants need to be between 18 and 70 years old, have a body mass index (BMI) of 28 or higher, and be scheduled for a gastroendoscopy or colonoscopy that lasts no longer than 45 minutes. They also need to be in good overall health, with no severe medical conditions or contraindications that would prevent the use of the airway device. Participants can expect to sign an informed consent form and will be monitored closely during the procedure to ensure their safety. This trial is important as it seeks to improve the care and safety of obese patients undergoing these common medical procedures.

Gender

ALL

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.