Status:
RECRUITING
The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway in Gastrointestinal Endoscopy Procedure
Lead Sponsor:
RenJi Hospital
Conditions:
Hypoxia
Gastric Polyp
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing gastrointestinal endoscopy with propofol. A recent innovation in this domain is the COMBO Endoscopy Orop...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 27 2025
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT06081647
Start Date
December 27 2023
End Date
December 27 2025
Last Update
June 25 2025
Active Locations (10)
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1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210029
2
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
3
Shangdong Provincial Qianfoshan Hospital
Jinan, Shandong, China, 250014
4
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032