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New oxygen device may make endoscopy safer for the sickest patients

NCT ID NCT07252102

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a high-flow nasal cannula (HFNC) can prevent dangerous drops in oxygen levels during sedated gastrointestinal endoscopy in critically ill patients. Researchers will compare HFNC with standard nasal oxygen in 450 adults with serious health conditions. The goal is to see if HFNC reduces the chance of hypoxia and other breathing problems during the procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
high-flow nasal cannula oxygen (device)
What this could lead to
If it works, this could provide a safer way to perform endoscopy in critically ill patients, reducing the risk of dangerously low oxygen levels.
What could go wrong
This is a relatively small, early-stage trial. The device may not reduce hypoxia significantly, and results may not apply to all critical patients. Risks include nasal discomfort or injury from the high-flow device.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

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 80 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: 1. 18≤ age ≤80, gender is not limited; 2. Patients undergoing elective gastroenteroscopy or treatment; 3. ASA grade Ⅲ\~Ⅳ; 4. 18 kg/m2≤BMI≤28kg/m2; 5. The operation time of gastroenteroscopy is expected to be no more than 60min; 6. Clearly understand, voluntarily participate in the study, and have informed consent from myself or my family members. Exclusion Criteria: 1. Patients with nasal congestion, nasal bleeding, recent nasal trauma, recent nasal surgery, increased intracranial pressure and skull fracture, etc., who can not perform high-flow nasal catheter oxygen; 2. acute respiratory infections and asthma attacks; 3. Patients diagnosed with COPD; 4. Clear difficult airway; 5. Acute upper gastrointestinal bleeding with shock; 6. Gastrointestinal obstruction with gastric content retention; 7. Allergic to sedatives such as propofol; 8. Persons with no capacity for civil conduct such as cognitive dysfunction.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

    RECRUITING

    Shenzhen, Guangdong, 518116, China

  • Shenzhen Hospital of Southern Medical University

    RECRUITING

    Shenzhen, Guangdong, 518000, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

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