跳至主要内容
临床试验/NCT06313671
NCT06313671已完成不适用

Reliability of Plethysmographic Perfusion Index to Predict Fluid Responsiveness in Acute Circulatory Failure.

Avicenna Military Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Reliability and accuracy of the perfusion index to discriminate fluid-responsiveness.

研究概览

简要总结

The objective of this study is to assess the reliability of the perfusion index to predict fluid responsiveness in patients with acute circulatory failure in intensive care.

详细描述

In patients with acute circulatory failure, it is recommended to assess fluid responsiveness. Fluid responsiveness is defined by an increase in cardiac output of 10 to 15% after fluid loading. The assessment of fluid responsiveness usually needs cardiac output monitoring (or stroke volume). However, in limited resource settings or during the initial management of patients with acute circulatory failure, cardiac output measurement is usually unavailable. The perfusion index (PI) is derived from the plethysmographic signal of the pulse oximeter and represents the ratio between the ratio of pulsatile on non-pulsatile light absorbance of the plethysmography signal. The PI is influenced by vascular and stroke volume. The investigators hypothesized that the peripheral index could track the changes in cardiac output induced by fluid loading and therefore detect fluid responsiveness.

Adult patients with acute circulatory failure in whom physicians want to test the fluid responsiveness will be included. At baseline, the PI will be recorded. An initial echocardiography will be performed to measure the left ventricular outflow tract velocity time integral (a surrogate of stroke volume). A fluid loading with 500 ml of 0.9% Saline or Ringer Lactate will be performed. After fluid administration, the velocity time integral and the PI will be collected. Fluid-responsive patients are defined by a 15% increase in velocity time integral. The investigators will analyze the ability of the PI to detect fluid responsiveness.

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

入选标准

  • Patients aged 18 and older with acute circulatory failure (ACF).

排除标准

  • Low echogenicity: the inability to perform echocardiographic measurements according to established recommendations.
  • Absence of the plethysmographic signal.

结局指标

主要结局

Reliability and accuracy of the perfusion index to discriminate fluid-responsiveness.

时间窗: through study completion, an average of 9 months.

Reliability and accuracy of the change in perfusion index to discriminate fluid-responsive patients. Fluid responsiveness is defined by an increase in the left ventricular outflow tract velocity time integral by 15% after fluid loading.

次要结局

未报告次要终点

研究者

发起方
Avicenna Military Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Younes Aissaoui, MD

Professor of Anesthesiology and Intensive Care Medicine - Head of intensive care unit

Avicenna Military Hospital

研究点 (1)

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