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临床试验/NCT03757312
NCT03757312已完成不适用

A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass

Marco Corridore1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2019年4月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
14
试验地点
1
主要终点
Optic Nerve Sheath Diameter

研究概览

简要总结

The purpose of the proposed study is to evaluate the incidence of subtle increases in intracranial pressure (ICP) following cardiopulmonary bypass (CPB) using optic nerve sheath diameter (ONSD), measured by non-invasive ultrasound. As direct measurements of ICP are not feasible following CPB, ONSD will be used as a correlate of ICP. ONSD has been shown to be effective in the ICU and emergency room setting for detecting increased ICP and is an accepted standard for such measurements. The primary hypothesis is that changes in ICP occur following CPB without clinically appreciable signs and symptoms. These changes in ICP will be reflected by changes in ONSD. If there is a significant incidence of sub-clinical cerebral edema and increased ICP postoperatively, these findings may impact postoperative hemodynamic and ventilation goals and techniques.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients less than 18 years of age undergoing cardiac bypass.

排除标准

  • 未提供

研究组 & 干预措施

Fontan

Experimental

Patients undergoing Fontan procedure to redirect blood flow from the lower body to the lungs.

干预措施: Ultrasound (Diagnostic Test)

Non-Fontan

Active Comparator

Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass.

干预措施: Ultrasound (Diagnostic Test)

结局指标

主要结局

Optic Nerve Sheath Diameter

时间窗: Day of surgery

Optic nerve sheath diameter normal values: ≤4.0 mm for patients \<1 year and ≤4.5 mm used for patients ≥1 year of age, thus there is potential for worse outcomes with higher diameters.

次要结局

  • Optic Nerve Sheath Diameter: Short Versus Long Cardiopulmonary Bypass (CPB) Time(Day of surgery)

研究者

发起方
Marco Corridore
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Marco Corridore

Associate Professor of Anesthesiology

Nationwide Children's Hospital

研究点 (1)

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