The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway in Gastrointestinal Endoscopy Procedure
Hypoxia, Gastric Polyp, Colon Cancer
About this trial
This is an interventional prevention trial for Hypoxia focused on measuring the COMBO Endoscopy Oropharyngeal Airway, Hypoxia, Gastrointestinal Endoscopy, Propofol, Sedation
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.
Sites / Locations
- The First Affiliated Hospital with Nanjing Medical University
- Shangdong Provincial Qianfoshan Hospital
- Fudan University Shanghai Cancer Center
- Renji Hospital
- The First Affliated Hospital of Xi'an Jiangtong University
- Tianjin Mediacal University General Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
the COMBO Endoscopy Oropharyngeal Airway Group
Regular Nasal Cannula Group
In this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
In this group, patients use the regular nasal cannula for oxygenation.