COMBO Endoscopy Oropharyngeal Airway in Sedated Fiberoptic Bronchoscopy for Patients: A Simon Two-Stage Trial

Launched by ZHEJIANG UNIVERSITY · Jul 3, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new device called the COMBO Endoscopy Oropharyngeal Airway, designed to help patients breathe better during a procedure called fiberoptic bronchoscopy, which examines the lungs and airways. When patients are sedated with a medicine called propofol during this procedure, low oxygen levels (hypoxia) can sometimes happen, which can be dangerous. This new device combines several helpful features—including monitoring breathing, supporting oxygen supply, and protecting the airway—to see if it can reduce the chances of low oxygen during the procedure.

Adults aged 18 to 60 who need a fiberoptic bronchoscopy and are generally healthy (with mild or no other medical issues) may be eligible to join, as long as the procedure is expected to last less than 45 minutes. People with certain health problems, like breathing issues, infections, or those who might have trouble using the airway device, won’t be able to participate. If you join the trial, you’ll receive sedation as usual, but the new airway device will be used to help keep your breathing safe and steady. The study will check if this device makes breathing during the procedure safer and easier for patients like you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18≤ Age ≤60.·Patients undergoing fiberoptic bronchoscopy.
• • 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 with contraindications to oropharyngeal airway ventilation, such as coagulation disorders, predisposition to oral/nasal bleeding, mucosal damage, or anatomical obstructions hindering oropharyngeal airway placement.
• • Patients diagnosed with acute exacerbation of chronic obstructive pulmonary disease (COPD) or those currently suffering from other acute/chronic pulmonary conditions requiring long-term or intermittent oxygen therapy.
• • Patients with preoperative SpO₂ \< 95% while breathing air.
• • Patients with BMI \< 18.5 or BMI \> 30.
• • Patients with upper respiratory tract infections (oral, nasal, or pharyngeal).
• • Patients at risk of aspiration.
• • Patients with fever (core temperature \> 37.5°C).
• • Patients with severe cardiac insufficiency (\< 4 METs).
• • Patients with severe renal insufficiency requiring preoperative dialysis.
• • Patients with a confirmed diagnosis of hepatic insufficiency.
• • Patients with increased intracranial pressure.
• • Patients with hypersensitivity to sedatives like propofol or medical equipment such as adhesive tape.
• • Patients with a history of drug abuse and/or alcoholism within the two years preceding the commencement of the screening period (defined as drinking 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.
• • Patients currently participating in other clinical trials.
• • Patients deemed ineligible for participation in this clinical trial by the researchers.