Noninvasive Measurement of CO Using Impedance Cardiography in Patients With CHD
Noninvasive Measurement of Cardiac Output Using Impedance Cardiography in Patients With Congenital Heart Disease
研究概览
详细说明
The measurement of cardiac output (CO) is important for a wide variety of patients under multiple conditions. At present, gold standard techniques for measurement of CO include velocity encoded phase contrast MRI. Both of these techniques are valid in patients with structural CHD. Disadvantages of these techniques include the requirement of significant time and expertise, and the high cost and anesthesia requirement. Accurate, non-invasive tools to measure CO could be extremely valuable for patients with CHD that require one-time of continuous monitoring of CO, such as during surgery, in intensive care settings, during other diagnostic testing, and during different physiologic states such as sleep and exercise. This study would begin by comparing cardiac output based on the PhysioFlow monitor to cardiac outout by MRI.
Impedance cardiography is performed by placing electrodes on the thorax and neck to measure electrical impedance over time. Cardiac output is derived from these measurements. The technique has been studied, validated, and used extensively in adults and has also been shown to be valid in children with structurally normal hearts. In contrast, recent studies of children with CHD have shown a relatively poor agreement between impedance cardiography and both thermodilution technique and velocity encoded phase contrast MRI. The reasons for the poor agreement in CHD patients is not yet understood. There are proprietary algorithms in each impedance device that use the raw data to calculate and report cardiac output. If the physiologic and/or anatomic differences of patients with CHD require changing the algorithm within each system to account for such differences, that needs to be done to each system. In order to do this, owners of any given device (PhysioFlow, NeuMeDx Inc. in this case) need access to the raw data in order to alter the algorithm. This study will involve a concerted effort between investigators at RCHSD, UCSD, and NeuMeDx
研究类型
注册 (实际的)
联系人和位置
学习地点
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California
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San Diego、California、美国、92123
- Rady Children's Hospital
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Any form of congenital heart disease
- Any age
Exclusion Criteria:
- Subjects with significant clinical skin reactions to electrodes such as excessive pain and/or skin inflammation, or significant previous skin reaction
- Subjects who are not able to provide consent
- Subjects with pacemaker
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
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CHD patients undergoing cardiac MRI without sedation
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impedance cardiography instrument that measures cardiac output non-invasively
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Mean Difference in Stroke Volume Between CMR and SMIC
大体时间:2 hours
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Mean difference in stroke volume (SV) between CMR and SMIC measurements in ml
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2 hours
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Physioflow的临床试验
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Centre Hospitalier Universitaire, AmiensCentre Hospitalier de Lens完全的