NCT06796764 COMBO Endoscopy Oropharyngeal Airway Reduces Hypoxia During Sedated Gastrointestinal Endoscopy in Obese Patients: A Multicenter, Randomized, Controlled Clinical Trial
| NCT ID | NCT06796764 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhejiang University |
| Condition | Hypoxia |
| Study Type | INTERVENTIONAL |
| Enrollment | 580 participants |
| Start Date | 2025-04-11 |
| Primary Completion | 2025-12-04 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 580 participants in total. It began in 2025-04-11 with a primary completion date of 2025-12-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. 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\<28 kg/m². * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06796764 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Hypoxia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06796764 currently recruiting?
Yes, NCT06796764 is actively recruiting participants. Contact the research team at diansansu@yahoo.com for enrollment information.
Where is the NCT06796764 trial being conducted?
This trial is being conducted at Hangzhou, China, Hangzhou, China, Hangzhou, China.
Who is sponsoring the NCT06796764 clinical trial?
NCT06796764 is sponsored by Zhejiang University. The trial plans to enroll 580 participants.