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Eye ultrasound may spot brain swelling during aortic surgery

NCT ID NCT07800806

Knowledge-focused Sponsor: Koşuyolu Kartal Heart 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 This study
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 Results may not be published yet.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
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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This status has not been confirmed recently, so it may be out of date.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 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This study tests whether ultrasound of the optic nerve sheath, a marker of brain pressure, can track brain swelling during ascending aortic surgery. Researchers will measure the optic nerve sheath diameter before, during, and after surgery in 134 adults undergoing this procedure. They will also check whether changes in these measurements relate to postoperative delirium. The goal is to see if this simple, non-invasive test could help monitor brain health during complex heart surgery.

What this could mean

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

Active substance
Ocular ultrasonography and transcranial Doppler ultrasonography as diagnostic monitoring tests
What this could lead to
If it works, this could point toward a simple, non-invasive way to monitor brain swelling during aortic surgery and help prevent postoperative delirium.
What could go wrong
This is an observational study, so it cannot prove cause and effect. The ultrasound measurements may not reliably reflect brain pressure, and results may not apply to other surgical 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 134 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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

18 years and older

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: * Age 18 years or older * Planned or urgent, hemodynamically stable ascending aortic surgery, including supracoronary ascending aortic replacement, aortic root replacement (Bentall procedure) or valve-sparing root surgery (David procedure), limited to cases involving the ascending aortic segment * Perfusion planned through axillary artery cannulation * Written informed consent Exclusion Criteria: * History of intracranial procedure or intracranial pathology * Previous carotid intervention, or carotid artery stenosis of 50 percent or more on preoperative Doppler ultrasonography * Advanced chronic obstructive pulmonary disease, defined clinically as advanced stage disease with long-term oxygen therapy or a history of frequent exacerbations * Baseline arterial carbon dioxide tension of 55 mmHg or higher on preoperative arterial blood gas analysis * Ocular pathology, ocular surgery or ocular trauma that could affect measurement of the optic nerve sheath or optic nerve, including glaucoma and retinal detachment or fibrosis * Severe preoperative neurological deficit, including major stroke or severe dementia, or active psychiatric illness * Hemodynamic instability, or a requirement for extracorporeal membrane oxygenation or intra-aortic balloon counterpulsation, of a degree that prevents measurements during the first 24 postoperative hours * Known contraindication to any component of the protocol-specified anesthesia regimen

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Conditions

The condition(s) this trial relates to.

aortic disorder Emergence Delirium Postoperative Complications thoracic aortic aneurysm

As listed by the trial registrant

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

Aortic aneurysm, thoracic Aortic diseases Cardiac surgical procedures Cerebrovascular circulation Delirium - postoperative Postoperative complications Postoperative complications (cardiopulmonary)

How to take part

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  1. The places running it

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  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

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Contacts and locations

Locations

  • Kosuyolu Heart Training and Research Hospital

    Istanbul, Kartal, 34862, Turkey (Türkiye)

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