跳至主要内容
临床试验/NCT03094325
NCT03094325已完成不适用

On-pump Intraoperative Echocardiography (OPIE)

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年3月23日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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