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Computer coach for ventilators could help kids breathe easier

NCT ID NCT04068012

Knowledge-focused Sponsor: Children's Hospital Los Angeles 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a computer program that gives doctors step-by-step advice on how to set breathing machines for children with acute respiratory distress syndrome (ARDS). The goal is to see if the tool can be used in multiple hospitals and if doctors follow its recommendations. Up to 180 children on ventilators will take part. If the tool works well, a larger study will check if it helps children spend less time on breathing machines.

What this could mean

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

Active substance
computerized decision support tool for ventilator management
What this could lead to
If successful, this tool could help standardize ventilator care for children with lung injury, potentially reducing time on breathing machines and improving outcomes.
What could go wrong
This is a small pilot study focused on feasibility, not on proving the tool works. It may not show clear benefits, and results may not apply to all hospitals.

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 180 people

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

Started

Dec 2020

Expected to finish

Jul 2027

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

1 month to 18 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: * Children \> 1 month of age and \>44 weeks gestation and ≤ 18 years of age AND * Supported on mechanical ventilation with pulmonary parenchymal disease (i.e. Pediatric Acute Respiratory Distress Syndrome (PARDS)) with Oxygen Saturation Index (OSI) ≥ 5) or Oxygenation Index (OI) ≥ 4 AND * Who are within 72 hours of initiation of invasive mechanical ventilation AND * Who are anticipated to require \>72 hours mechanical ventilation. Exclusion Criteria: * Conditions on enrollment that preclude conventional methods of weaning (i.e., status asthmaticus, severe lower airway obstruction, bronchiolitis, critical airway, Extra Corporeal Life Support (ECLS), intubation for Upper Airway Obstruction, Do Not Resuscitate orders, severe chronic respiratory failure, spinal cord injury above lumbar region, cyanotic heart disease (unrepaired or palliated)) OR * Conditions precluding the use of permissive hypercapnia or hypoxemia (i.e. intracranial hypertension, severe pulmonary hypertension) * Primary Attending physician refuses to enroll the patient

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Conditions

The condition(s) this trial relates to.

acute lung injury acute respiratory distress syndrome pediatric acute respiratory distress syndrome Ventilator-Induced Lung Injury

As listed by the trial registrant

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

ARDS Ventilation therapy; complications Ventilator induced lung injury

How to take part

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

  1. The places running it

    8 sites in 3 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

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    RECRUITING

    Chicago, Illinois, 60611, United States

  • CHU Sainte-Justine

    RECRUITING

    Montreal, Quebec, Canada

  • Children's Hospital of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Ospedale Pediatrico Bambino Gesu

    NOT_YET_RECRUITING

    Roma, Italy

  • Penn State University

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Riley Hospital for Children

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • University of Utah

    NOT_YET_RECRUITING

    Salt Lake City, Utah, 84112, United States

  • University of Wisconsin-Madison

    RECRUITING

    Madison, Wisconsin, 53715, United States

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