The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway in Gastrointestinal Endoscopy Procedure

Launched by RENJI HOSPITAL · Oct 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the COMBO Endoscopy Oropharyngeal Airway, which aims to help patients breathe more easily during gastrointestinal endoscopy procedures. The goal is to see if this device can reduce the risk of low oxygen levels (hypoxia) when patients are sedated with a medication called propofol. The device combines several features, including a way to monitor breathing, support for oxygen, and management of the airway, all designed specifically for these procedures.

To participate in the trial, individuals must be between 18 and 60 years old and scheduled for a gastroendoscopy or colonoscopy that lasts no longer than 45 minutes. They also need to agree to take part by signing a consent form. However, not everyone can join; those with certain health conditions, such as severe heart or lung problems, or who are pregnant, will not be eligible. If you meet the criteria and enroll, you can expect to undergo the endoscopy while the new airway device is used, and your breathing and oxygen levels will be closely monitored throughout the procedure.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18≤ Age ≤60.
• • Patients undergoing gastroendoscopy and/or colonoscopy procedure.
• • Patients have signed the informed consent form.
• • The ASA classification ranges from I to II.
• • 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\<18.5 or BMI\>30.
• • 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.