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临床试验/NCT04416009
NCT04416009Unknown不适用

the Determination of Extracellular Water (ECW) Which is Detected by Bioimpedence Method on Severe and Mild Covid 19 Pneumonia Clinical Course

Gaziosmanpasa Research and Education Hospital1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2020年7月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
52
试验地点
1
主要终点
ECW

研究概览

简要总结

According to various studies Covid 19 pneumonia has a very similar clinical course to Acute Respiratory Distress Syndrome (ARDS) which has clarified by Berlin definition. Based on this similarity, extracellular fluid of lungs and diffuse alveolar damage should be observed in covid 19 pneumonia as well. Extracellular water (ECW) can be determine by using whole body bioimpedence system (NİCaS). The aim of this study is to investigate the effect of ECW on the clinical apperence of covid 19 pneumonia clinical course.

详细描述

Increase in the extracellular water of lungs is the major pathophisilogy of ARDS. According to various studies Covid 19 pneumonia has a very similar clinical course to Acute Respiratory Distress Syndrome (ARDS) which has clarified by Berlin definition. Depending on the similarity of Covid 19 and ARDS; evaluation of ECW ,can be a determinant of clinical apperence of covid19 pneumonia. The aim of this study to find the corelation between ECW and severty of the pneumonia.

In this prospective -controlled research, the patients who were diagnosed with Covid-19 pneumonia will be evaluated. The ones in the intensive care will be considered as severe, and the ones in the ward will be considered as mild clinical course pneumonia. İn both groups, in addition to other heamodynamic parametres, ECW will be recorded using non-invasive body biooimpedence method by NİCaS machine. The total amount of patients will be 52, 26 each two groups.

The ward and intensive care patients will be connected to the NİCaS machine to determine ECW and statistically significantchanges will be recorded. The device consists of a laptop, a software which calculates cardiac parameters and two electrodes. The measurement is done by the following process: one of these electrodes, which looks like ECG electrodes, is stuck to the wrist and the other one to the opposite ankle or each one to two wrists.

the severety of illness will try to be detected.Gpower 3 for Mac Os (Faul, F., Erdfelder, E., Buchner, A., & Lang, A.-G. (2009). Statistical power analyses using G*Power 3.1: Tests for correlation and regression analyses. Behavior Research Methods, 41, 11491160.) was used for istatistical power analysis.The power analysis was done priorly and based on the T-test.In order to provide enoughsample magnitude power, which is 0.8, it was calculated that each group should have 26 patients which makes at total of 52 Statistical method: The normal distribution of data will be evaluated using Kolmogorov-Smirnov test. Parametric ones will be used in normal distrubitions, non-parametric ones will be used in abnormal distrubitions. İntergroup ECW values will be compared via independent sample T test. In catagoric data, the comparisons will be made with Pearson Ki square test, and the p values less then 0.05 will be considered as significant.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Covid 19 pneumonia, hospitalized patients older than 18

排除标准

  • younger than 18 years old, patients not infected with covid 19

结局指标

主要结局

ECW

时间窗: three measurements with half an hour intervals

Changes of three measurements of extracellular water in both lungs

次要结局

未报告次要终点

研究者

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

SİBEL BEKTAŞ

director

Gaziosmanpasa Research and Education Hospital

研究点 (1)

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