COMBO endoscopy oropharyngeal airway for safer propofol‑sedated gastrointestinal endoscopy

The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway Reduce the Incidence of Hypoxia in Patients Undergoing Gastrointestinal Endoscopy Sedated With Propofol.

This trial will test whether the COMBO Endoscopy Oropharyngeal Airway reduces low-oxygen episodes in adults having propofol‑sedated gastroscopy or colonoscopy compared with a regular nasal cannula.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1200 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Locations: 10 sites (Nanjing, Jiangsu and 9 other locations)
• Trial ID: NCT06081647 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–60 undergoing gastroscopy or colonoscopy under propofol sedation with ASA physical status I–II and an expected procedure time under 45 minutes who can give informed consent.

Not a fit: People over age 60, ASA class III or higher, those with COPD or other chronic pulmonary disease, active need for prolonged oxygen therapy, anatomical contraindications to oropharyngeal airway placement, or severe cardiac/renal/hepatic dysfunction are excluded and unlikely to benefit from this device in this study.

Why it matters

Potential benefit: If successful, the COMBO device could reduce episodes of low oxygen during propofol‑sedated endoscopy and improve procedural safety.

How similar studies have performed: Related approaches using oropharyngeal airways, supplemental oxygen, and capnography have shown reductions in hypoxic events in sedation settings, but device-specific data for the COMBO airway are limited.

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.

Where this trial is running

Nanjing, Jiangsu and 9 other locations

• 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)
• Xinhua Hospital Affliated To Shanghai Jiaotong University School Of Medicine — Shanghai, Shanghia, China (Recruiting)
• The First Affliated Hospital of Xi'an Jiangtong University — Xi’an, Shanxi, China (Recruiting)
• Tianjin Mediacal University General Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
• The First Affliated Hospital, Zhejiang University School Of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Diansan Su, Dr.

Conditions Hypoxia; Gastric Polyp; Colon Cancer; Esophageal Cancer; the COMBO Endoscopy Oropharyngeal Airway; Gastrointestinal Endoscopy; Propofol; Sedation