NCT07063290CompletedPhase 2
COMBO Endoscopy Oropharyngeal Airway in Sedated Fiberoptic Bronchoscopy for Patients: A Simon Two-Stage Trial
Source: ClinicalTrials.gov · Last updated 24 Feb 2026
Brief summary (registry, in English)
Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing fiberoptic bronchoscopy with propofol. 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 our randomized study is to assess the efficacy and safety of the COMBO Endoscopy Oropharyngeal Airway reduce the incidence of hypoxia on patients undergoing fiberoptic bronchoscopy under propofol sedation.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 104 (actual)
- First submitted
- 29 Jun 2025
- Start date
- 23 Jun 2025
- Primary completion date
- 18 Sept 2025
- Lead sponsor
- Zhejiang University
- NCT number
- NCT07063290
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 104
- From 23 Jun 2025 to the primary completion date, 18 Sept 2025
- 1 site 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.
Other illness
- 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 upper respiratory tract infections (oral, nasal, or pharyngeal).
- 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 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.
Other
- Patients with preoperative SpO₂ \< 95% while breathing air.
- Patients with BMI \< 18.5 or BMI \> 30.
- Patients at risk of aspiration.
- Patients with fever (core temperature \> 37.5°C).
- Patients with increased intracranial pressure.
- Patients currently participating in other clinical trials.
- Patients deemed ineligible for participation in this clinical trial by the researchers.
Who the study is looking for
- Age 18≤ Age ≤70.·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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affliated Hospital, Zhejiang University School Of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.