On-pump Intraoperative Echocardiography (OPIE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Septal Thickness Measured Before Cardiopulmonary Bypass
研究概览
简要总结
This pilot study uses an ultrasound probe that is currently clinically used to assess pituitary anatomy, the Hitachi-Aloka high resolution pituitary transducer to measure left ventricular (LV) septal thickness during cardiopulmonary bypass in the performance of surgical septal myectomy. Septal thickness will be assessed and can be visualized during the procedure and if it is likely to improve the efficacy and safety of the procedure. The probe has FDA clearance for a variety of intra-operative surgical procedures but will be off-label for this cardiac surgical protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Each of the 10 patients will have 4 measurements(OPIE & TEE before cardiopulmonary bypass and OPIE & TEE after cardiopulmonary bypass) in the septum using two techniques (TEE and OPIE Ultrasound Probe).
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled to receive a septal myectomy.
排除标准
- •Less than 18 years of age
结局指标
主要结局
Septal Thickness Measured Before Cardiopulmonary Bypass
时间窗: 1 Day
Center tendency parameters(mean, standard deviation)
次要结局
未报告次要终点
