Konya City Hospital
Konya, Karatay, 42020, Turkey (Türkiye)
NCT Number: NCT05930691
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.
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All sexes
Observational
Konya, Karatay, 42020, Turkey (Türkiye)
INTRODUCTION Mortality rates for newborns with congenital heart disease (CHD) have dramatically decreased thanks to surgical methods and medical treatment improvements. As a result, more emphasis is being put on reducing neonatal cardiac surgery morbidity.
Extracorporeal life support (ECLS) is increasingly being given to children, particularly for cardiac causes, according to the Pediatric Extracorporeal Life Support Organization Registry's global report. However, up to 70% of patients may have post-ECLS cerebral dysfunction, which can result in long-term cognitive and motor impairment, first showing as brain edema and higher intracranial pressure (ICP). In addition, pediatric patients may have trouble being diagnosed with acute elevations in IİCP since the signs and symptoms are sometimes unclear.
The gold standard for measuring intracranial pressure (ICP) still involves invasive intracranial devices. In addition, ICP monitors have the potential to cause complications, including bleeding in 1.1-5.8% of cases, malfunction, in 6.3-40% of cases, or infection in 0-15% of cases, with a noticeable higher risk of bacterial colonization after five days.
The optic nerve sheath surrounds the Optic Nerve (ON) and covers the optic subarachnoid space, which is connected to the intracranial subarachnoid space area. Changes in intracranial pressure are thus straightly transferred to the optic nerve sheath. Therefore, Optic Nerve Sheath Diameter (ONSD) is a non-invasive method of measuring Intracranial Pressure (ICP).
Longer ECLS periods and aortic cross-clamp times have been linked to more frequent CT detection of cerebral edema, according to prior investigationsAccording to prior investigations, long ECLS periods, and aortic cross-clamp times have been linked to more frequent CT (computer tomography) detection of cerebral edema. However, there is currently no information on the relationship between these time points and the ONSD determined by ultrasound.
The Primary Aim of this study was to identify the correlation between ONSD and ECLS time in newborns who get ECLS. Specifically, we tested the primary hypothesis that more ECLS time means more ONSD valuable over the perioperative period. Our secondary aim was to investigate the relationship between ONSD and aortic cross-clamp time and operation time and also, operation time and preoperative and intraoperative perioperative ONSD variation for the ECLS period.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Prediction of intracranial pressure by using Ultrasonography on optic nerve sheath diameter.
Time frame: Basal; the 15. minutes after aort cross clamp; the time of removing cross clamp; End of the operation.
The Primary outcome of this study will be identifing ONSD in ECLS time in newborns.
Time frame: Basal; the 15. minutes after aort cross clamp; the time of removing cross clamp; End of the operation.
Our secondary outcome will be ONSD in aortic cross-clamp time.
Time frame: Basal; the 15. minutes after aort cross clamp; the time of removing cross clamp; End of the operation.
Our secondary outcome will be ONSD in operation time.
Time frame: Basal; the 15. minutes after aort cross clamp; the time of removing cross clamp; End of the operation.
Our secondary outcome will be ONSD variation for the ECLS period.
Konya City Hospital
Other
Evaluation of the Association Between the Optic Nerve Sheath Diameter and Extracorporeal Life Support Time During Cardiac Surgery in Newborn
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