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Ultrasound may help pick better breathing tubes for kids with heart defects

NCT ID NCT07586592

Knowledge-focused Sponsor: Ain Shams University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares using ultrasound versus an age-based formula to choose the correct breathing tube size for children aged 3 months to 8 years with single ventricle heart conditions. The goal is to see which method leads to fewer breathing tube placement attempts and less post-surgery airway problems like stridor. The trial is currently recruiting 60 participants at Ain Shams University.

What this could mean

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

Active substance
Ultrasound device and Cole's formula (age-based calculation)
What this could lead to
If ultrasound proves more accurate, it could reduce breathing tube complications in children with single ventricle heart conditions.
What could go wrong
This is a small, early-stage study (60 participants) comparing two methods, not testing a new treatment. Results may not apply to all children or settings.

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 60 people

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

Started

Jan 2026

Expected to finish

Jun 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

3 months to 8 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: * Pediatric patients (3 months to 8 years) * Patients with single ventricle physiology * Scheduled for Glenn or Fontan surgery or cardiac catheterization * Patients with Glenn or Fontan shunt scheduled for surgery Exclusion Criteria: * Refusal of legal guardians * Emergency surgery * Patients with tracheostomy tubes * Recent or active upper respiratory tract infection * Airway anomalies (e.g. Pierre Robin, Treacher Collins) * ICU stay due to complications other than that of airway

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Conditions

The condition(s) this trial relates to.

univentricular cardiopathy univentricular heart

As listed by the trial registrant

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

Endotracheal tube wrongly placed during anesthetic procedure

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

  • Ain Shams University

    RECRUITING

    Cairo, Abbasseya, 00202, Egypt

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