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A simple ventilation tweak might make Kids' anesthesia safer

NCT ID NCT07767851

Disease control Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This trial tests whether using a breathing support method (PEEP and pressure support) during anesthesia induction in children reduces the risk of breathing problems like laryngospasm, bronchospasm, and low oxygen levels. The study will include over 2,000 children aged 3 months to 6 years undergoing surgery with inhalational anesthesia. Half will receive the standard spontaneous breathing approach, while the other half will get the added breathing support. The goal is to see if this technique can lower the rate of respiratory complications during this critical phase.

What this could mean

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

Active substance
A ventilation technique using positive end-expiratory pressure (PEEP) and pressure support ventilation (PSV) during inhalational anesthesia induction in children.
What this could lead to
If effective, this ventilation approach could become a standard practice to reduce serious breathing complications during anesthesia induction in children, improving safety.
What could go wrong
The trial is early and results may not confirm the benefit. The technique requires careful adjustment by an anesthesiologist and may not suit all children.

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 2,032 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 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

3 months to 6 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: * Child between 3 months and 6 years old * Without significant comorbidity (ASA 1 or 2) * Admitted for elective or emergency/urgent surgery under general anesthesia * With induction of anaesthesia by inhalation by sevoflurane on the machine circuit * With airway control by intubation tube or supraglottic device * Consent of at least one parent or legal guardian Exclusion Criteria: * Children with severe upper respiratory tract infection (severe moist cough, fever and lethargy, oxygen requirement) in the last 7 days requiring intravenous induction or postpone of the surgery * Thoracic surgery with selective control of intubation * Criteria for difficult intubation or known history of difficult intubation * Children with a contraindication to sevoflurane (ex: risk of malignant hyperthermia) * Children asking for intravenous induction or requiring rapid sequence induction * Children with significant cardiac disease (pulmonary hypertension, cyanotic heart disease,…) * Children not affiliated or beneficiary of a health insurance system * Children participating in other interventional research with an exclusion period still in progress at inclusion Exclusion Criteria : * Failure of venous access after 30 min or more than 5 attempts * Parents' consent withdrawal

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Conditions

The condition(s) this trial relates to.

Respiratory Aspiration

As listed by the trial registrant

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

Anaesthetic induction Pediatrics Respiratory complications of care Ventilation

How to take part

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

  1. The places running it

    9 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

  • CHU Toulouse - Hôpitaux des enfants

    Toulouse, 31300, France

  • CHU de Nantes

    Nantes, 44000, France

  • Centre Hospitalier Universitaire de Montpellier

    Montpellier, 34295, France

  • Centre Hospitalier Universitaire de Reims

    Reims, 51092, France

  • Hôpital Armand Trousseau

    Paris, 75012, France

  • Hôpital Femme Mère Enfant

    Lyon, 69677, France

  • Hôpital Robert Debré

    Paris, 75019, France

  • Hôpital de Hautepierre

    Strasbourg, 67200, France

  • Hôpitaux Universitaires de Marseille Timone

    Marseille, 13385, France

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