the Determination of Extracellular Water (ECW) Which is Detected by Bioimpedence Method on Severe and Mild Covid 19 Pneumonia Clinical Course
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
- 否
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
SİBEL BEKTAŞ
director
Gaziosmanpasa Research and Education Hospital
