跳至主要内容
临床试验/NCT01090791
NCT01090791终止不适用

Assessment of the FLOTRAC/VIGILEO Third Generation Software to Predict Fluid Responsiveness in Critically Ill Patient With Acute Circulatory Failure

Hôpital Européen Marseille2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
1
试验地点
2
主要终点
Stroke volume measurement between Flotrac/Vigileo device and transthoracic echocardiography

研究概览

简要总结

Acute circulatory failure may be related to hypovolemia. Fluid loading increases stroke volume in approximatively half of challenges. Determining fluid responsiveness prevents unnecessary fluid loading. Passive leg raising (PLR) provides a transient increase of 300 ml in venous return for a short time. The measurement of stroke volume (SV) before and after a PLR test allows physician to detect fluid responsiveness, when stroke volume increases is higher than 15 %. Beside thermodilution, the use of non invasive device to measure stroke volume becomes largely employed. Arterial Pressure based Cardiac Output (APCO), provided by the Flotrac/Vigileo system, does not required specific materials nor repeated calibration. The third generation software is believed to be more accurate and more precise for SV measurement. The aim of this study is to test the performance of the Flotrac/Vigileo device in a situation of rapid venous return changes induced by PLR and then by fluid loading. Patients will be classify posteriorly in responders and non responders, according to the magnitude of the fluid loading-induced SV changes measured by transthoracic echocardiography.

研究设计

研究类型
Observational
观察模型
Case Crossover
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

入选标准

  • Systolic arterial pressure < 90 mmHg or Mean arterial pressure < 60 mmHg
  • Heart rate > 100 bpm
  • Norepinephrine infusion
  • Urine output < 0.5 ml/kg/h during at least two consecutive hours
  • skin mottling
  • Capillary refill time > 3 sec

排除标准

  • Acute cor pulmonale
  • Ongoing renal replacement therapy
  • Lack of echogenicity during transthoracic echocardiography

结局指标

主要结局

Stroke volume measurement between Flotrac/Vigileo device and transthoracic echocardiography

时间窗: 30 min

Bland-Altman analysis of the whole SV measurements

次要结局

  • SVV cut-off with Flotrac/Vigileo to predict fluid responsiveness(30 min)
  • SV cut-off with Flotrac/Vigileo and with TEE to predict fluid responsiveness(30 min)

研究者

发起方
Hôpital Européen Marseille
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jerome Allardet-Servent, MD

MD, MSc

Hôpital Européen Marseille

研究点 (2)

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