A breathing device tested during sedated stomach and food pipe endoscopy in obese adults
Tests a breathing airway device to reduce low oxygen during sedated endoscopy in obese adults.
Plain-language title generated from the registry record
Registry title: COMBO Endoscopy Oropharyngeal Airway Reduces Hypoxia During Sedated Gastrointestinal Endoscopy in Obese Patients: A Multicenter, Randomized, Controlled Clinical Trial
Key facts
- Where
- Hangzhou, ChinaSee the 3 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06796764, who can take part
Where in China
- The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaTaking people
- The Fourth Affiliated Hospital, Zhejiang University School of MedicineHangzhou, ChinaTaking people
- Zhejiang Cancer HospitalHangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zhejiang University
- Trial code
- NCT06796764
- Record updated
- 10 September 2025
- Original description
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.Read full original descriptionShow less
COMBO Endoscopy Oropharyngeal Airway Reduces Hypoxia During Sedated Gastrointestinal Endoscopy in Obese Patients: A Multicenter, Randomized, Controlled Clinical Trial
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.
Inclusion: 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: Urgent surgical intervention; Presently engaged in concurrent participation in additional clinical trials; 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; 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.