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Which breathing setting keeps Kids' lungs healthier during heart surgery?

NCT ID NCT07754591

Disease control Sponsor: Nilratan Sircar Medical College 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial asks whether one way of setting a breathing machine is better than another for children born with a hole in the heart who are having surgery to close it. The hole lets extra blood flow to the lungs, which can make them stiff and harder to inflate. During surgery, a machine breathes for the child, and it can be set to control either the pressure or the volume of each breath. Researchers are comparing these two settings to see which keeps the lungs easier to inflate and lets air move more freely through the breathing tubes.

What this could mean

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

Active substance
Pressure-controlled ventilation (PCV) compared with volume-controlled ventilation (VCV) during mechanical ventilation in pediatric heart surgery
What this could lead to
If one setting proves better, it could guide safer breathing support for children during heart surgery, potentially improving lung function and recovery.
What could go wrong
This is a small, early-stage comparison in a specific group of children, so results may not apply broadly. Both settings are standard, and differences may be minor.

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

72 people

The number who actually took part.

Started

Jul 2024

Finished

Dec 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

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: * Paediatric patients aged 1 month to 18 years * Left-to-right intracardiac shunt lesions (atrial septal defect or ventricular septal defect) undergoing corrective surgery under cardiopulmonary bypass - Elevated pulmonary artery pressure: pulmonary artery systolic pressure 30 mmHg or above, and/or mean pulmonary artery pressure 20 mmHg or above Exclusion Criteria: * Refusal to participate * Presence of any other associated cardiac anomaly * Allergy to milrinone * Associated coagulation disorder * Sepsis * Neurological disorder * Hepatic or renal dysfunction * Failure to wean from cardiopulmonary bypass

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Conditions

The condition(s) this trial relates to.

atrial septal defect heart septal defect pulmonary hypertension ventricular septal defect

As listed by the trial registrant

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

Atrial septal defect Intracardiac and septal defects Pulmonary hypertension Ventricular septal defects

Contacts and locations

Locations

  • Nil Ratan Sircar Medical College and Hospital

    Kolkata, West Bengal, 700014, India

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