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

Launched by ZHEJIANG UNIVERSITY · Feb 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the COMBO Endoscopy Oropharyngeal Airway, which is designed to help prevent low oxygen levels (hypoxia) during sedation for gastrointestinal endoscopy procedures in obese patients. This trial aims to see how well this device works when used with High-Flow Nasal Cannula Oxygenation, which provides extra oxygen through a special tube placed in the nose. Obese patients often experience hypoxia during these procedures, and this study seeks to improve their safety and comfort.

To participate in the trial, patients need to be between 18 and 70 years old, have a body mass index (BMI) of 35 or higher, and be scheduled for a gastroendoscopy or colonoscopy that lasts no longer than 45 minutes. However, certain conditions may exclude individuals from joining, such as severe heart or lung problems, pregnancy, or recent substance abuse. Participants will receive the new airway device during their procedure and will be monitored closely for any changes in their oxygen levels. It's important for patients and their families to understand both the benefits and the requirements of this study.

Gender

ALL

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.