跳至主要内容
临床试验/NCT03241069
NCT03241069已完成不适用

Dynamic Variation of Impedance Cardiography (ICG) a Diagnostic Tool of Acute Heart Failure (AHF) in Emergency Department (ED) Patients Admitted for Acute Dyspnea

University of Monastir2 个研究点 分布在 1 个国家目标入组 290 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
290
试验地点
2
主要终点
Cardiac output rate measured by ICG before and during maneuvers in acute dyspneic patients between the AHF and non AHF groups

研究概览

简要总结

Dynamic variations of bio-impedance measured cardiac output using non pharmacologic intervention (sitting position, passive leg rising and valsalva maneuver) could be used to detect acute heart failure in patients admitted to the ED for dyspnea.

详细描述

Acute heart failure (AHF) is a frequent condition in emergency basis and is responsible of a big number of admissions, complications, and deaths.

despite advances in diagnostic techniques, AHF diagnosis still difficult and cost not effective.

Measurement of cardiac output (CO) is used as a way to evaluate global cardiac function and changes in CO may be used to identify a change in the hemodynamic status of a patient.

the gold standard of measuring CO is thermodilution catheterization, however this is an invasive technique that poses a risk to the patient.

Impedance cardiography (ICG) is a noninvasive method for measuring CO. it is performed by applying small electrical current to the chest, and through electrodes placed on the neck and sides.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Care Provider, Outcomes Assessor)

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

  • 18 year old or above
  • non traumatic acute dyspnea

排除标准

  • age <18 years,
  • cardio respiratory arrest,
  • need for inotropic or vasoactive drugs,
  • mechanical ventilation,
  • severe and sustained rhythm disorders,
  • severe mitral valve disease,
  • severe pulmonary arterial hypertension
  • renal insufficiency with creatinine>150 μmol/l.

结局指标

主要结局

Cardiac output rate measured by ICG before and during maneuvers in acute dyspneic patients between the AHF and non AHF groups

时间窗: 12 hours

The diagnostic performance of each maneuver is evaluated by calculating the CO in ml/min by bio-impedance technique and compare the values between patients with and without AHF and between baseline. The diagnosis of AHF is based on clinical, biological (BNP levels), radiological (chest X-ray) and cardiac ultrasound data.

次要结局

  • In hospital death(up to 10 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pr. Semir Nouira

Professor

University of Monastir

研究点 (2)

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