A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass
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
Patients undergoing Fontan procedure to redirect blood flow from the lower body to the lungs.
干预措施: Ultrasound (Diagnostic Test)
Non-Fontan
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
Marco Corridore
Associate Professor of Anesthesiology
Nationwide Children's Hospital
