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Completed

NCT Number: NCT05047653

RALE Versus CORADS/CT-Severity Score in COVID-19

Rationale Patients with severe coronavirus disease 2019 (COVID-19) frequently fulfill the criteria for acute respiratory distress syndrome (ARDS), with extensive and bilateral abnormalities on the chest radiography (CXR) and the chest computed tomography (CT) abnormalities. The 'Radiographic Assessment of Lung Edema' (RALE) score, the 'COVID-19 Reporting and Data System' (CO-RADS) score, and the 'CT severity score' may all have prognostic value in critically ill patients with acute respiratory failure due to COVID-19.

Objectives To compare the prognostic value of the RALE score, the CO-RADS score and the CT severity score in critically ill patients with ARDS due to COVID-19.

Hypotheses The RALE score, the CO-RADS score and the CT severity score have prognostic value (primary). The RALE score, the CO-RADS score and the CT severity score correlate well.

Study design National, retrospective observational study. Study population Critically ill COVID-19 patients with acute respiratory failure, who received at least one CXR and one chest CT scan during critical illness.

Method CXRs are visually scored by two independent investigators, using the RALE score approach. Chest CT scans are scored by an independent radiologist, using the CO-RADS score and the CT severity score. Demographic, ventilation and outcome data are captured from the hospital systems.

Main study parameters/endpoints ICU mortality (primary) and hospital-, 28-, 90-mortality, the number of days alive and free from invasive ventilation, duration of ventilation in survivors, and length of stay in ICU and hospital.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness Participants will not directly benefit from participation, but burden is absent. The CRX and chest CT scans have already been obtained as part of routine clinical care. Collecting CXR for RALE scoring and chest CT scans for CO-RADS and CT severity scoring, clinical and outcome data is of no harm for individual patients.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Amsterdam, Netherlands

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • admitted to the intensive care unit of the Amsterdam UMC, location 'AMC', between March 1, 2020 and May 31, 2020 (the first 3 months of the first wave of the national outbreak in the Netherlands) and between October 1, 2020 and December 31, 2020 (the first 3 months of the second wave in the Netherlands);
  • RT-PCR confirmed coronavirus diseases 2019 (COVID-19); and
  • having had received at least one chest radiograph (CXR) and one adjacent chest computed tomography (CT) scan during the period a patient was having acute respiratory failure.

Exclusion criteria

  • Age < 18 years.

Treatment and study plan

RALE score vs. severity score

Diagnostic Test

RALE score vs. severity score and CORADS

Primary outcomes

  1. ICU mortality

    Time frame: 90 days

    The ICU mortality with a maximum of 90 days

Secondary outcomes

  1. hospital mortality

    Time frame: 90 days

    The hospital mortality with a maximum of 90 days

  2. 28-day mortality

    Time frame: 28 days

    The 28-day mortality

  3. 90-day mortality

    Time frame: 90 days

    The 90-day mortality

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

The Prognostic Value of the Abnormalities on the Chest Radiography Versus the Chest Computed Tomography in Critically Ill COVID-19 Patients - Protocol for a National Study Comparing the RALE With the CORADS and CT-Severity Score

Acronym: RALE-CORADS

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 17, 2021
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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