Clinical Evaluation of a New Transpulmonary Thermodilution Method to Assess TPTD, GEDV and EVLW
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 4
- 主要终点
- TPTD, GEDV and EVLW measurements to evaluate the precision and accuracy of a novel algorithm in comparison to the widely accepted TPTD method
研究概览
简要总结
The primary objective of this study is to obtain the TPTD, GEDV and EVLW measurements from existing indwelling femoral arterial Volume View™ catheter and central venous catheters.
详细描述
Transpulmonary thermodilution has been proposed to measure transpulmonary thermodilution cardiac output (TPTD), preload (GEDV, global end diastolic volume) and to quantify pulmonary edema (EVLW, extravascular lung water). The method currently available on the market is based on the estimation of time characteristics of the curve (mean transit time and down slope time).
The purpose of this study is to evaluate a new transpulmonary thermodilution method to assess the TPTD, EVLW and GEDV in patients requiring cardiac preload and lung water assessment. Up to one hundred (100) patients will be enrolled at four (4) study sites, (up to 25 subjects at each site). Hôpitaux Universitaires de Genève, Universität Bonn, Stadtspital Triemli Zürich, and Universitätsklinikum Aachen will participate in the study.
This is a prospective, observational data collection study.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have clinical need for an indwelling femoral arterial catheter and central venous catheter.
- •Patient, or legal guardian, must sign consent to be in the study prior to data capture.
- •Patient must be at least 18 years old.
- •Patient height and weight are available prior to study.
排除标准
- •Patients with significant aortic valve regurgitation.
- •Patients being treated with an intra-aortic balloon pump.
- •Patients less than 40 kg in weight.
- •Female patients with a known pregnancy or planned pregnancy.
- •Patient is currently participating in an investigational drug or another device study that clinically interferes with the study endpoints.
- •Patients with peripheral vascular disease.
- •Patients with aortic aneurysm.
结局指标
主要结局
TPTD, GEDV and EVLW measurements to evaluate the precision and accuracy of a novel algorithm in comparison to the widely accepted TPTD method
时间窗: Up to 72 hours of femoral arterial catheter dwell time.
This is not an outcome study. This is an observational Study to obtain TPTD, GEDV and EVLW data to evaluate the precision and accuracy of a novel algorithm in comparison to the widely accepted TPTD method using an approach defined by Bland-Altman.
次要结局
未报告次要终点