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New breathing tube swap could prevent Kids' Post-Surgery breathing problems

NCT ID NCT07204990

Symptom relief Sponsor: Telethon Kids Institute Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether swapping a breathing tube (ETT) for a mask (LMA) while a child is still asleep, then removing the mask when they wake up, leads to fewer breathing problems than removing the tube directly when the child is awake. About 1,400 children aged 0-16 having surgery will be randomly assigned to one of the two methods. The goal is to find out which approach is safer and reduces complications like coughing, low oxygen, and airway spasms.

What this could mean

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

Active substance
Laryngeal mask airway (LMA) inserted after deep removal of endotracheal tube
What this could lead to
If it works, this could lead to a safer, standard way to remove breathing tubes in children, reducing coughing, low oxygen, and other breathing issues after surgery.
What could go wrong
This is a single study in children having planned surgery, so results may not apply to all kids or emergency cases. The new technique might not be better and could cause other problems like airway blockage.

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 1,400 people

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

Started

Feb 2026

Expected to finish

Feb 2029

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

0 to 16 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.

Participant Inclusion Criteria * Children 0-16 years, * 5kg and above, * presenting for elective, semi-elective or emergency surgery under general anaesthesia * With airway management planned with an endotracheal tube. Exclusion Criteria: * Children with severe cardiopulmonary disease or syndrome * Children \< 5kg * Children with a contraindication to deep removal of ETT deep or exchange of ETT to LMA at the end of the case (e.g. high risk of aspiration) * Children with a known or anticipated difficult airway * Children remaining intubated post-procedure * Children undergoing major airway surgery or bronchoscopies

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Airway anesthesia Endotracheal extubation Paediatric

How to take part

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

  1. The places running it

    7 sites in 6 countries. 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

  • Atrium Health Wake Forest Baptist

    NOT_YET_RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Bern University Hospital

    NOT_YET_RECRUITING

    Bern, Switzerland

  • Istituto Giannina Gaslini

    NOT_YET_RECRUITING

    Genova, Italy

  • Perth Children's Hospital

    RECRUITING

    Nedlands, Western Australia, 6909, Australia

  • The Children's Hospital of Philadelphia

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19104-4313, United States

  • The Kids Research Institute Australia

    ACTIVE_NOT_RECRUITING

    Nedlands, Western Australia, 6909, Australia

  • University of São Paulo

    NOT_YET_RECRUITING

    São Paulo, Brazil

  • Uppsala University Hospital

    RECRUITING

    Uppsala, Sweden

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