Evaluation of the Association Between the Optic Nerve Sheath Diameter and Extracorporeal Life Support Time During Cardiac Surgery in Newborn
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Correlation between optic nerve sheath diameter and extra corperal support life time.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA III or IV status newborn;
- •Have surgery for transposition of great arteries (TGA).
排除标准
- •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.
结局指标
主要结局
Correlation between optic nerve sheath diameter and extra corperal support life time.
时间窗: 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.
次要结局
- Staticticaly meaningful between operation time and optic nerve sheath diameter(Basal; the 15. minutes after aort cross clamp; the time of removing cross clamp; End of the operation.)
- Perioperative ONSD variation for the ECLS period.(Basal; the 15. minutes after aort cross clamp; the time of removing cross clamp; End of the operation.)
- Staticticaly meaningful between Cross clamp time and optic nerve sheath diameter(Basal; the 15. minutes after aort cross clamp; the time of removing cross clamp; End of the operation.)
研究者
Aydın Mermer
Vice Director, Head of Anesthesiology, Principal Investigator, Clinical Speicialist
Konya City Hospital