Lung Ultrasound Findings in Patients With COVID-19 in a UK ED

October 14, 2021 updated by: Chelsea and Westminster NHS Foundation Trust

Lung Ultrasound Findings in Patients With COVID-19 in a UK Emergency Department

The investigators aim to carry out a retrospective observational study, analysing lung ultrasound images from patients who have presented to A&E for routine diagnostic purposes (ruling out cardiogenic pulmonary oedema, Pulmonary embolism and pericardial effusions) and systematically assessing for abnormalities typical for COVID-19 infection (Pleural irregularities, B lines, consolidations, pleural effusions). Doing this, the investigators will also develop a suggestion for a standardised technique for lung ultrasound which can be transferred to other clinical settings (Intensive Care, Acute medical Unit) and could form the basis for an international standard. Thirdly, the investigators aim to correlate our findings to clinical severity judged by oxygenation status on arrival in ED. To the investigators' knowledge, this is the first study of this kind.

Study Overview

Status

Completed

Conditions

Detailed Description

COVID-19 is a new disease significant morbidity and mortality which has reached pandemic status. Due to its highly contagious nature, is essential to characterise the disease pathology quickly and reliably. The lung changes that can be seen in patients with COVID-19 can precede clinical symptoms and are picked up on ultrasound more reliably than on conventional chest XR. In addition, ultrasound is devoid of harmful radiation, is quick to perform, and easily learned by doctors who routinely use ultrasound such as in the Emergency Department. To date, there is no data systematically analysing the ultrasound changes in COVID-19 and relating this to disease severity. The data from our study will be contribute significantly to developing strategies for safe triage with regards to cohorting, diagnosis and prognosis of COVID-19.

In this research study, lung ultrasound scans will be retrospectively analysed that were obtained from patients who presented to the emergency department during March-May 2020 with shortness of breath, who were subsequently diagnosed with COVID-19 either by PCR test or composite diagnostic criteria of lymphopenia and positive Chest XR or CT scan report.

The lung ultrasound images will be retrospectively scored for the presence of absence of 5 lung abnormalities (pleural irregularity, B lines, small peripheral consolidation, large consolidation, small effusion (<1cm) and large effusion (>1cm). Scoring will be performed by 2 independent observers with experience in lung ultrasound. In addition, each abnormality will be analysed for preferential location within the lung.

The patients will be grouped into 4 groups of clinical severity (normal oxygenation, mild, moderate and severe deficit in oxygenation) based on the BERLIN criteria for ARDS, and lung abnormalities as seen on lung ultrasound will be analysed for correlation to clinical severity.

Study Type

Observational

Enrollment (Actual)

43

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

  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, SW10 9NH
        • Chelsea And Westminster Hospital

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

Adult patients with COVID-19 viral infection.

Description

Inclusion Criteria:

  • Presented to the ED between March-May 2020 with dyspnoea
  • COVID-19 positive either by PCR test or composite diagnostic criteria of lymphopenia and positive Chest XR report
  • Received lung ultrasound as part of investigations during ED attendance

Exclusion Criteria:

  • < 18 years of age
  • Not diagnosed with COVID-19

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Normal oxygenation
Normal oxygenation based on the BERLIN criteria for ARDS
Mild deficit in oxygenation
Mild deficit in oxygenation based on the BERLIN criteria for ARDS
Moderate deficit in oxygenation
Moderate deficit in oxygenation based on the BERLIN criteria for ARDS
Severe deficit in oxygenation
Severe deficit in oxygenation based on the BERLIN criteria for ARDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterisation of lung changes in COVID-19 patients as seen on ultrasound
Time Frame: 2-3 months

Retrospective scoring of lung ultrasound images (12-zone ultrasound where clinical status allowed) for each of 5 lung abnormalities (pleural irregularity, B lines, small peripheral consolidation, large consolidation, small effusion (<1cm) and large effusion (>1cm).

The images will be scored by 2 independent observers and the scores will be analysed based on the occurrence, location within the lung and clinical correlation
2-3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of lung changes as seen on ultrasound with clinical severity as per the Berlin ARDS criteria
Time Frame: 2-3 months

Patients will be grouped into 4 groups of clinical severity (normal oxygenation, mild, moderate and severe deficit in oxygenation) based on the BERLIN criteria for ARDS.

The data will be analysed by standard statistical tests comparing binomial data between unpaired and paired groups, as well as comparing more than three unmatched groups. This will include Chi-square, McNemar and paired t-tests and one-way ANOVA tests
2-3 months

Collaborators and Investigators

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

Sponsor

Chelsea and Westminster NHS Foundation Trust

Investigators

  • Principal Investigator: Paramjeet Deol, MBChB FRCEM, paramjeet.deol@chelwest.nhs.uk

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 29, 2020

Primary Completion (Actual)

December 12, 2020

Study Completion (Actual)

December 12, 2020

Study Registration Dates

First Submitted

September 30, 2021

First Submitted That Met QC Criteria

September 30, 2021

First Posted (Actual)

October 4, 2021

Study Record Updates

Last Update Posted (Actual)

October 22, 2021

Last Update Submitted That Met QC Criteria

October 14, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C&W20/050
  • IRAS number 286642 (Other Identifier: Integrated Research Application System)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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