Finger Plethysmographic Cardiac Output Monitoring to Predict Fluid Responsiveness in Healthy Pregnancy and Women Diagnosed With Preeclampsia and Severe Features
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Prediction Accuracy for Change in Cardiac Output for Fluid Responsiveness
研究概览
简要总结
The goal of this observational study is to determine whether noninvasive finger plethysmographic cardiac output monitoring can help predict fluid responsiveness in pregnant women, including those with preeclampsia with severe features.
The main questions it aims to answer are :
- Can changes in cardiac output measured by finger plethysmography predict fluid responsiveness?
- How does this method perform compared with standard echocardiographic assessment? Participants will provide consent and undergo noninvasive hemodynamic monitoring and a brief reversible physiological challenge.
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
- 是
入选标准
- •Women diagnosed with preeclampsia with severe features following ACOG recommendations (systolic/diastolic BP >160/110 mmHg, proteinuria, or other severe features like headaches, visual disturbances, kidney/liver impairment, thrombocytopenia).
- •Healthy pregnant women at term (for comparison group, e.g., scheduled for elective Cesarean delivery).
排除标准
- •Patients who can not provide written consent to participate in the study
- •BMI greater than 40 kg/m²
- •Multiple pregnancy (twins, triplets, etc.)
- •Non-reassuring fetal heart tracing
- •≤ 22 weeks gestation
- •History of chronic arterial hypertension
- •Chronic kidney disease
- •Congenital or known acquired heart disease
- •Chronic obstructive pulmonary disease
- •History of stroke
- •Not tolerating passive leg raising (unable to be placed in the required study position)
- •No TTE-windows
- •Withdrawing consent
- •Emergency cesarean delivery
研究组 & 干预措施
Healthy pregnant women
Pregnant participants without hypertensive disorders enrolled for brief, noninvasive hemodynamic assessments
干预措施: Noninvasive finger plethysmographic cardiac output monitoring (Diagnostic Test)
Healthy pregnant women
Pregnant participants without hypertensive disorders enrolled for brief, noninvasive hemodynamic assessments
干预措施: Standard transthoracic echocardiographic assessment (Diagnostic Test)
Preeclampsia With Severe Features
Women diagnosed with preeclampsia with severe features enrolled for brief, noninvasive hemodynamic assessments
干预措施: Noninvasive finger plethysmographic cardiac output monitoring (Diagnostic Test)
Preeclampsia With Severe Features
Women diagnosed with preeclampsia with severe features enrolled for brief, noninvasive hemodynamic assessments
干预措施: Standard transthoracic echocardiographic assessment (Diagnostic Test)
结局指标
主要结局
Prediction Accuracy for Change in Cardiac Output for Fluid Responsiveness
时间窗: Baseline (semi-recumbent) and 1 minute after passive leg raising
Prediction accuracy (ROC-AUC) of percent change in cardiac output measured by noninvasive finger plethysmographic device during passive leg raising to identify fluid responsiveness (TTE reference)
次要结局
- Prediction Accuracy for Change in Pulsatility Index for Fluid Responsiveness(Baseline (semi-recumbent) and 1 minute after passive leg raising)
- Prediction Accuracy for Change in Stroke Volume for Fluid Responsiveness(Baseline (semi-recumbent) and 1 minute after passive leg raising)
- Prediction accuracy for Pulsatility Index at Baseline(Baseline (semi-recumbent))
- Prediction accuracy for Stroke Volume at Baseline(Baseline (semi-recumbent))
- Prediction accuracy for Cardiac Output at Baseline(Baseline (semi-recumbent))
- Optimal Diagnostic Cut-Off and Operating Characteristics for Device Parameters(Baseline (semi-recumbent) and 1 minute after passive leg raising)
- Inter-observer and Intra-observer Variability for Measurements(Baseline (semi-recumbent) and 1 minute after passive leg raising)
研究者
Clemens Ortner
Clinical Professor
Stanford University