NCT06796764Recruiting
COMBO Endoscopy Oropharyngeal Airway Reduces Hypoxia During Sedated Gastrointestinal Endoscopy in Obese Patients: A Multicenter, Randomized, Controlled Clinical Trial
Source: ClinicalTrials.gov · Last updated 10 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing gastrointestinal endoscopy with propofol. This is particularly true for obese patients, who have a higher incidence of hypoxia. A recent innovation in this domain is the COMBO Endoscopy Oropharyngeal Airway-a multifaceted device that encompasses capnography monitoring, bite block , oxygenation support, and oropharyngeal airway management. This device has been purposefully designed to cater to the unique requirements of endoscopic procedures. The principal objective of this study is to assess the efficacy and safety of the COMBO Endoscopy Oropharyngeal Airway in reducing the incidence of hypoxia in obese patients undergoing gastrointestinal endoscopy under sedation.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 580 (estimated)
- First submitted
- 22 Jan 2025
- Start date
- 11 Apr 2025
- Primary completion date
- 4 Dec 2025
- Lead sponsor
- Zhejiang University
- Diseases
- Obesity, Gastric and esophageal cancer
- NCT number
- NCT06796764
What you commit to
- Study type: Interventional
- Planned participants: 580
- From 11 Apr 2025 to the primary completion date, 4 Dec 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Urgent surgical intervention.
- Presently engaged in concurrent participation in additional clinical trials.
Other illness
- 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.
- Patients diagnosed with chronic obstructive pulmonary disease (COPD) or those presently experiencing other acute and chronic pulmonary conditions necessitating prolonged or intermittent oxygen therapy.
- Upper respiratory tract infections, encompassing the oral, nasal, and pharyngeal regions.
- Hypersensitivity reactions to sedatives like propofol or medical equipment such as adhesive tape.
- 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.
Other
- A confirmed severe liver dysfunction.
- Elevated intracranial pressure.
- Fever, defined as a core body temperature exceeding 37.5 degrees Celsius.
- Pregnancy or lactation.
- Polytrauma.
- Peripheral oxygen saturation (SpO2) levels below 95% while breathing room air preoperatively.
- BMI\<28 kg/m².
- Patients considered ineligible by researchers for inclusion in this clinical trial.
Who the study is looking for
- Age 18≤ Age ≤70.
- BMI ≥ 28 kg/m².
- The ASA classification ranges from I to II.
- Patients have signed the informed consent form.
- Patients undergoing gastroendoscopy and colonoscopy procedure.
- The estimated duration of the procedure does not exceed 45 minutes.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The Fourth Affiliated Hospital, Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.