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New combo device aims to keep patients breathing safely during lung scope
NCT ID NCT07063290
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a new device called the COMBO Endoscopy Oropharyngeal Airway in 104 adults undergoing a sedated lung procedure (fiberoptic bronchoscopy). The device combines oxygen delivery, airway support, and breathing monitoring into one tool. The goal was to see if it could reduce episodes of low oxygen (hypoxia) compared to standard care. If successful, it could make these common procedures safer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- COMBO Endoscopy Oropharyngeal Airway (a device that provides oxygen, monitors breathing, and keeps the airway open)
- What this could lead to
- If it works, this device could reduce the risk of dangerously low oxygen levels during sedated bronchoscopy, making the procedure safer and more comfortable.
- What could go wrong
- This is a small, early-phase trial (104 people) testing a device, not a new drug. The device may not work better than standard care, and results may not apply to all patients or longer procedures.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
104 people
The number who actually took part.
- Started
-
Jun 2025
- Finished
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Sep 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
The First Affliated Hospital, Zhejiang University School Of Medicine
Hangzhou, Zhejiang, 310000, China
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