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临床试验/NCT05299229
NCT05299229已完成不适用

Continuous Non-invasive Hemodynamic Monitoring in Early-onset Severe Preeclampsia: a Comparison of Echocardiography, Bioreactance, and Finger Cuff Measurements

Yale University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年12月29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
12
试验地点
1
主要终点
Change in cardiac output (L/min) as measured by NICOM (bioreactance) monitoring

研究概览

简要总结

The purpose of this study is to compare the feasibility and accuracy of two methods of non-invasive hemodynamic assessments - bioreactance as assessed by non-invasive cardiac output monitoring (NICOM; Cheetah Medical) and pulse wave analysis as assessed by finger cuff arterial pressure (ClearSite, Edwards Life Sciences) - compared to hemodynamic assessments by intermittent echocardiography in early onset preeclampsia.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • BP >160 or DBP >110
  • gestational age between 20-34 weeks
  • singleton pregnancy

排除标准

  • prior diagnosis of chronic hypertension or hypertensive disorder of pregnancy
  • multi-fetal pregnancy

结局指标

主要结局

Change in cardiac output (L/min) as measured by NICOM (bioreactance) monitoring

时间窗: Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)

Cardiac output (L/min) ranges 3-10 L/min, lower values associated with more severe preeclampsia

Change in systemic vascular resistance (dynes/sec*cm-5) as measured by NICOM (bioreactance) monitoring

时间窗: Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)

Systemic vascular resistance ranges 600-2000 dynes/sec\*cm-5, higher values associated with more severe preeclampsia

Change in Cardiac output (L/min) as measured by Clearsite (pulse wave analysis) monitoring

时间窗: Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)

Cardiac output (L/min) ranges 3-10 L/min, lower values associated with more severe preeclampsia

Change in Cardiac output (L/min) as measured by transthoracic echocardiography

时间窗: Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)

Cardiac output (L/min) ranges 3-10 L/min, lower values associated with more severe preeclampsia

Change in Systemic vascular resistance (dynes/sec*cm-5) as measured by Clearsite (pulse wave analysis) monitoring

时间窗: Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)

Systemic vascular resistance ranges 600-2000 dynes/sec\*cm-5, higher values associated with more severe preeclampsiaanalysis) monitoring

Change in Systemic vascular resistance (dynes/sec*cm-5) as measured by transthoracic echocardiography

时间窗: Baseline (typically 3-5 days before birth, but can be up to 5 weeks before birth), 3 days after birth (postpartum)

Systemic vascular resistance ranges 600-2000 dynes/sec\*cm-5, higher values associated with more severe preeclampsia

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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