Extracellular Water in Covid 19 Pneumonia
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|ClinicalTrials.gov Identifier: NCT04416009|
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
|Condition or disease||Intervention/treatment|
|Extracellular Fluid Alteration Corona Virus Infection||Device: NİCaS|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||52 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||the Determination of Extracellular Water (ECW) Which is Detected by Bioimpedence Method on Severe and Mild Covid 19 Pneumonia Clinical Course|
|Estimated Study Start Date :||July 5, 2020|
|Estimated Primary Completion Date :||December 20, 2020|
|Estimated Study Completion Date :||February 20, 2021|
mild pneumonia ECW
the covid 19 pneumonia patients who hospitalised to the ward
whole body bioimpedence method
severe pneumonia ECW
the covid 19 pneumonia patients who hospitalised to the intensive care unit
whole body bioimpedence method
- ECW [ Time Frame: three measurements with half an hour intervals ]Changes of three measurements of extracellular water in both lungs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04416009