跳至主要内容
临床试验/NCT04484298
NCT04484298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 100 人开始时间: 2019年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Cardiac output variation measured by ICG before and after nitroglycerin in acute dyspneic patients between the AHF and non AHF groups

研究概览

简要总结

the study aimed to evaluate the diagnostic performance of cardiac output (CO) change after the use of trinitrine in the diagnosis of heart failure patients with acute dyspnea.

详细描述

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

despite advances in diagnostic techniques, AHF diagnosis still be challenging .

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

the gold standard of measuring CO is thermodilution catheterization, however it is an invasive technique with high risks.

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

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, 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

  • ECG diagnostic for acute myocardial infarction or ischemic chest pain within the prior 24 hours,
  • pericardial effusion ,
  • chest wall deformity suspected of causing dyspnea,
  • need for mechanical ventilation or vasopressor drugs,
  • serious and sustained arrhythmia,
  • pace maker,
  • severe mitral valve disease, severe pulmonary arterial hypertension,
  • renal failure (creatinine >350µmol/l.

结局指标

主要结局

Cardiac output variation measured by ICG before and after nitroglycerin in acute dyspneic patients between the AHF and non AHF groups

时间窗: 24 hours

the diagnostic performance 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.

Sensitivity, specificity, positive and negative predictive values, and likelihood ratios of positive and negative results were calculated using the optimal cutoff value of deltaCO.

时间窗: 24 hours

Sensitivity, specificity, positive and negative predictive values, and likelihood ratios of positive and negative results were calculated using the optimal cutoff value of deltaCO.

roc curve

时间窗: 24

Receiver operating characteristic (ROC) curves for predicting HF were constructed and area under curve (AUC) was measured for the deltaCO.

次要结局

未报告次要终点

研究者

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

Pr. Semir Nouira

professor semir nouira

University of Monastir

研究点 (2)

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