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Brain surgery breathing trick safe for kids, study finds

NCT ID NCT07370779

Knowledge-focused Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a specific breathing machine setting (PEEP) changes the size of the optic nerve sheath, which can indicate pressure inside the skull, in 30 children having brain surgery. The children were aged 6 months to 18 years and had a brain mass. The results showed that using a low PEEP level did not significantly change the nerve measurement and was safe, though it slightly lowered blood pressure within normal limits.

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

Jan 2021

Finished

Oct 2021

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

6 months to 18 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 aged 6 months to 18 years * American Society of Anesthesiologists (ASA) physical status III * Scheduled for elective craniotomy in the supine position * Presence of an extra-axial intracranial mass * Written informed consent obtained from parents or legal guardians Exclusion Criteria: * Open fontanelles * Orbital pathology * Severe increases in intracranial pressure associated with nausea, vomiting, visual disturbances, or seizures * Radiologic or clinical signs of brain herniation * Hydrocephalus * Cerebral infection * Congenital syndromes * History of surgery involving the optic nerve * Use of inotropic therapy * Hemodynamic instability * Surgical complications during the operation or procedures lasting longer than 8 hours * Postoperative intubation requiring intensive care unit follow-up * Tumors invading the optic nerve * Inability to obtain written informed consent from parents or legal guardians

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As listed by the trial registrant

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

Craniotomy surgery Optic nerve sheath diameter measurement Pediatric patient Pediatric patient safety Positive end-expiratory pressure (PEEP)

Contacts and locations

Locations

  • Dr Lutfi Kırdar City Hospital

    Istanbul, eyüpsultan, 34077, Turkey (Türkiye)

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