Chest Radiography in COVID-19 Patients

February 15, 2022 updated by: Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

139

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1105AZ
        • Amsterdam UMC location AMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Severe COVID-19 patients under invasive ventilation who received as part of standard care and routine imaging.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
The prognostic capacity of changes in the RALE score of consecutive CXRs under invasive ventilation in patients with severe COVID-19
Time Frame: 90 days
90 days
Number of ventilator-free day and alive at day 28 (VFD)
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

Mahidol University
Universitair Ziekenhuis Brussel
University of Bari Aldo Moro
Chonburi Hospital

Investigators

  • Principal Investigator: Marcus J. Schultz, Prof., Amsterdam University Medical Centers, location 'AMC'

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2020

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

September 1, 2021

Study Registration Dates

First Submitted

July 23, 2020

First Submitted That Met QC Criteria

July 23, 2020

First Posted (ACTUAL)

July 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RALE-COVID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe