COMBO endoscopy oropharyngeal airway for safer propofol‑sedated gastrointestinal endoscopy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized interventional comparison of the COMBO Endoscopy Oropharyngeal Airway versus a standard nasal cannula in adults undergoing gastroscopy and/or colonoscopy with propofol sedation. Participants (age 18–60, ASA I–II) who have procedures expected to last under 45 minutes will be randomly assigned to receive oxygenation and airway management via the COMBO device or routine nasal cannula support. The study will record the incidence of hypoxia, capnography and oxygenation metrics, and device-related adverse events and rescue airway interventions during the procedure. Safety and tolerability of the COMBO device will be monitored throughout the peri-procedural period.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital with Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting
• The First Affiliated Hospital Of Nanchang University
  Nanchang, Jiangxi, China Recruiting
• Shangdong Provincial Qianfoshan Hospital
  Jinan, Shandong, China Recruiting
• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting
• Renji Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• Tongji Hospital Of Tongji University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Diansan Su, Dr.
• Email: diansansu@yahoo.com
• Phone: +862168383702

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.