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New computer tool aims to keep Kids' diaphragms strong on ventilators

NCT ID NCT03266016

Disease control 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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This study tested a computer program called REDvent that helps doctors set ventilators to match a child's natural breathing effort. The goal was to prevent the diaphragm from weakening while on a breathing machine. Researchers enrolled 248 children with lung disease who needed ventilation. The program used real-time measurements to adjust support, and the team tracked muscle strength and time on the ventilator.

What this could mean

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

Active substance
Computerized ventilator protocol (REDvent)
What this could lead to
If successful, this approach could reduce the time children spend on ventilators and lower the risk of breathing muscle weakness.
What could go wrong
This is a Phase II trial with a moderate sample size; results may not confirm benefit in larger studies. The intervention is complex and may not work for 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

248 people

The number who actually took part.

Started

Oct 2017

Finished

Jun 2024

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

30 days 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 (\>44 weeks CGA) and ≤ 18 years of age AND * Supported on mechanical ventilation with pulmonary parenchymal disease (i.e., pneumonia, bronchiolitis, Pediatric Acute Respiratory Distress Syndrome (PARDS)) with Oxygen Saturation Index (OSI) ≥ 5 or Oxygenation Index (OI) ≥) AND * Who are within 48 hours of initiation of invasive mechanical ventilation (allow for up to 72 hours for those transferred from another institution) Exclusion Criteria: * Contraindications to use of an esophageal catheter (i.e. severe mucosal bleeding, nasal encephalocele, transphenoidal surgery) OR * Contraindications to use of RIP bands (i.e. omphalocele, chest immobilizer or cast) OR * Conditions precluding diaphragm ultrasound measurement (i.e. abdominal wall defects, pregnancy) OR * Conditions on enrollment that preclude conventional methods of weaning (i.e., status asthmaticus, severe lower airway obstruction, critical airway, intracranial hypertension, Extra Corporeal Life Support (ECLS), intubation for UAO, DNR, severe chronic respiratory failure, spinal cord injury above lumbar region, cyanotic heart disease (unrepaired or palliated)) OR * Primary Attending physician refuses (will be cleared with primary attending before approaching the patient).

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Conditions

The condition(s) this trial relates to.

diaphragm disorder

As listed by the trial registrant

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

Diaphragm disease Pediatric respiratory diseases Ventilation therapy; complications

Contacts and locations

Locations

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.