Extracellular Water in Covid 19 Pneumonia

NCT ID: NCT04416009

Last Updated: 2020-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-05

Study Completion Date

2021-02-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Extracellular Fluid Alteration Corona Virus Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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mild pneumonia ECW

the covid 19 pneumonia patients who hospitalised to the ward

NİCaS

Intervention Type DEVICE

whole body bioimpedence method

severe pneumonia ECW

the covid 19 pneumonia patients who hospitalised to the intensive care unit

NİCaS

Intervention Type DEVICE

whole body bioimpedence method

Interventions

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NİCaS

whole body bioimpedence method

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Covid 19 pneumonia, hospitalized patients older than 18

Exclusion Criteria

younger than 18 years old, patients not infected with covid 19
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gaziosmanpasa Research and Education Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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SİBEL BEKTAŞ

director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gaziosmanpaşa TREH

Istanbul, Gaziosmanpaşa, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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zuhal çavuş, MD

Role: primary

+902129453000 ext. 1436

aygen türkmen, Prof.MD

Role: backup

+902129453000 ext. 1641

References

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Tagami T, Ong MEH. Extravascular lung water measurements in acute respiratory distress syndrome: why, how, and when? Curr Opin Crit Care. 2018 Jun;24(3):209-215. doi: 10.1097/MCC.0000000000000503.

Reference Type BACKGROUND
PMID: 29608455 (View on PubMed)

Jozwiak M, Teboul JL, Monnet X. Extravascular lung water in critical care: recent advances and clinical applications. Ann Intensive Care. 2015 Dec;5(1):38. doi: 10.1186/s13613-015-0081-9. Epub 2015 Nov 6.

Reference Type BACKGROUND
PMID: 26546321 (View on PubMed)

Other Identifiers

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76

Identifier Type: -

Identifier Source: org_study_id

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