CompletedNot Applicable

Optic Nerve Sheath Diameter and the Duration of Extracorporeal Life Support During Newborn Cardiac Surgery

Turkey (Türkiye)22 participantsStarted 2023-05-15

Plain-language summary

Mortality rates for newborns with congenital heart disease (CHD) have dramatically decreased thanks to surgical methods and medical treatment improvements. Up to 70% of patients may have post- Extracorporeal life support (ECLS) cerebral dysfunction, which can result in long-term cognitive and motor impairment, first showing as brain edema and higher intracranial pressure (ICP). Optic Nerve Sheath Diameter (ONSD) is a non-invasive method of measuring Intracranial Pressure (ICP). The Primary Aim of this study is to identify the correlation between ONSD and ECLS time in newborns who get ECLS.

Who can participate

Age range

1 Day – 28 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ASA III or IV status newborn; * Have surgery for transposition of great arteries (TGA). Exclusion Criteria: * All off-pump cardiac surgery; * Recent history of cerebrovascular accident or intracranial hypertension due to any cause; * History of increased ICP; * Ophthalmological diseases capable of affecting optic nerve diameters.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Correlation between optic nerve sheath diameter and extra corperal support life time.

Timeframe: Basal; the 15. minutes after aort cross clamp; the time of removing cross clamp; End of the operation.

Trial details

NCT IDNCT05930691

SponsorKonya City Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-06-13

View on ClinicalTrials.gov More Extracorporeal Life Support trials