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NCT04485338 Clinical Trial

Chest Radiography in COVID-19 Patients

Covid19 Clinical Trial

Official title:
Radiographic Assessment of Lung Edema in Invasively Ventilated COVID-19 Patients (RALE-COVID) - Protocol for an International Multicenter Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04485338
Other study ID # RALE-COVID
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date September 1, 2021

Study information
Verified date February 2022
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To assess the prognostic performance of the RALE score with respect to duration of ventilation, and to describe changes in the RALE score over time.

Recruitment information / eligibility
Status Completed
Enrollment 139
Est. completion date September 1, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Admitted to an ICU participating in this study between December 1, 2019 and May 31, 2020 - Having had received invasive ventilation - Having had received at least one chest radiograph under invasive ventilation - Confirmed novel coronavirus diseases (COVID-19) Exclusion Criteria: - Age < 18 years

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands Amsterdam UMC location AMC Amsterdam

Sponsors (5)
Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Chonburi Hospital, Mahidol University, Universitair Ziekenhuis Brussel, University of Bari Aldo Moro

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary The prognostic capacity of the Radiographic Assessment of Lung Edema (RALE) score of the first CXR under invasive ventilation in patients with severe COVID-19. 90 days
Secondary The prognostic capacity of changes in the RALE score of consecutive CXRs under invasive ventilation in patients with severe COVID-19 90 days
Secondary Number of ventilator-free day and alive at day 28 (VFD) 28 days
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