NCT04416009

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

July 5, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2021

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

6 months

First QC Date

June 1, 2020

Last Update Submit

June 3, 2020

Conditions

Keywords

covid-19NİCaSpneumonia

Outcome Measures

Primary Outcomes (1)

  • ECW

    Changes of three measurements of extracellular water in both lungs

    three measurements with half an hour intervals

Study Arms (2)

mild pneumonia ECW

the covid 19 pneumonia patients who hospitalised to the ward

Device: NİCaS

severe pneumonia ECW

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

Device: NİCaS

Interventions

NİCaSDEVICE

whole body bioimpedence method

mild pneumonia ECWsevere pneumonia ECW

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hospitalized covid 19 patients

You may qualify if:

  • Covid 19 pneumonia, hospitalized patients older than 18

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpaşa TREH

Istanbul, Gaziosmanpaşa, 34255, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • 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.

    PMID: 29608455BACKGROUND
  • 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.

    PMID: 26546321BACKGROUND

MeSH Terms

Conditions

Coronavirus InfectionsCOVID-19Pneumonia

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

June 1, 2020

First Posted

June 4, 2020

Study Start

July 5, 2020

Primary Completion

December 20, 2020

Study Completion

February 20, 2021

Last Updated

June 4, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations