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New study tracks dangers of lung maneuver in kids with ARDS

NCT ID NCT07233304

Knowledge-focused Sponsor: Hospital de Alta Complejidad en Red 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tracks complications from a lung-opening procedure used in children under 14 with acute respiratory distress syndrome (ARDS) who are on a breathing machine. The procedure, called alveolar opening maneuver with PEEP titration, aims to improve oxygen levels but can cause side effects like low blood pressure or lung tears. Researchers will monitor 143 children in the PICU to see how often these complications occur, with the goal of making the procedure safer.

What this could mean

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

Active substance
Alveolar Opening Maneuver and PEEP Titration (a breathing procedure)
What this could lead to
If successful, this could help doctors perform the lung-opening maneuver more safely in critically ill children, reducing complications like low blood pressure or lung injury.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly improve outcomes. It only measures how often problems happen, and results may not apply to all hospitals or patients.

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.

Participants

About 143 people

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

Started

Aug 2025

Expected to finish

Aug 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.

Who is studied

All patients under 14 years of age admitted to the Pediatric Intensive Care Unit (PICU) of the Hospital Cuenca Alta Néstor Kirchner

Ages

1 month to 14 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: * Patients under 14 years of age admitted to the HCANK PICU * More than 4 hours of invasive mechanical ventilation (IMV) * An oxygenation index (OI) ≥4 or an oxygen saturation index (OSI) ≥5 * Indication for ARM and PEEP as determined by the treating team Exclusion criteria: * Predicted body weight (PBW) \>45.5 kg * Recent pulmonary resection surgery (\<7 days) * Presence of broncho-pleural fistula or peri-tube leak \>25% of the tidal volume * Hemoglobin decline \<7 g/dL * Patients with congenital or acquired heart diseases with significant intracardiac shunt.

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Conditions

The condition(s) this trial relates to.

acute lung injury acute respiratory distress syndrome adult acute respiratory distress syndrome pediatric acute respiratory distress syndrome

As listed by the trial registrant

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

Complication Oxygenation index Pediatric acute lung injury Pediatric intensive care unit Positive end-expiratory pressure (PEEP) Respiratory distress syndrome, pediatric

How to take part

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

  1. The places running it

    1 site. 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

  • Hospital Cuenca Alta Néstor Kirchner

    RECRUITING

    Canuelas, Buenos Aires, B1814, Argentina

More trials for these conditions

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