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Could a gentler breathing machine protect young hearts and brains after surgery?

NCT ID NCT04581668

NEW Knowledge-focused Sponsor: St. Justine's Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Children with congenital heart disease often need a breathing machine after surgery, and the pressure it creates can affect blood flow to the brain. This study compares conventional ventilation with NAVA, a mode that works with the child's own breathing signals, in 30 children recovering from heart surgery. Researchers measure brain blood flow, brain oxygenation, and heart function during each breathing mode to see whether NAVA makes a difference.

What this could mean

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

Active substance
Neurally Adjusted Ventilatory Assist (NAVA) ventilation, a breathing support mode that follows the patient's own diaphragm signals
What this could lead to
If NAVA improves brain blood flow and oxygenation, it could become a preferred ventilation approach for children recovering from congenital heart surgery.
What could go wrong
This is a small physiological study of 30 children at one hospital, so any differences may be short-lived or not apply to other patients. NAVA requires a special feeding tube and is not suitable for children with certain brain injuries or diaphragm paralysis.

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

30 people

The number who actually took part.

Started

Oct 2020

Finished

Feb 2026

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 day 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: 1. admission to the pediatric intensive care unit: * after Glenn, Fontan, Fallot Tetralogy surgery * or after other types of surgery with risk of post-operative occurence of right ventricular failure or low lung output 2. invasive ventilation scheduled for at least 2 hours after admission Exclusion Criteria: * Contraindication to placement of a nasogastric NAVA tube * History of significant focal brain injury (infarction or hemorrhage) * Bilateral phrenic paralysis * Extubation in operating room or planned to be within the hour, * Patient with open chest, uncontrolled shock, need for neuromuscular blockade. Note that for these criteria, the patient may become eligible when these criteria are resolved. * Patients for whom an acute care limitation order is in place.

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Conditions

The condition(s) this trial relates to.

congenital heart disease hypoplastic left heart syndrome tetralogy of fallot univentricular heart

As listed by the trial registrant

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

Heart defects, congenital Hypoplastic left heart syndrome Tetralogy of fallot Univentricular heart

Contacts and locations

Locations

  • St. Justine's Hospital

    Montreal, Quebec, H3T 1C5, Canada

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