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New combo device aims to keep patients breathing safely during lung scope

NCT ID NCT07063290

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.