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

Completed

• Conditions: Covid19; Corona Virus Infection; Coronavirus; SARS-CoV Infection

• Registration Number: NCT05065827
• Lead Sponsor: Chelsea and Westminster NHS Foundation Trust

Brief Summary

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.

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 Timeline

• Study Start: 2020-09-29
• Primary Completion: 2020-12-12
• Study Completion: 2020-12-12
• Study First Submitted: 2021-09-30
• Study First Submitted QC: 2021-09-30
• Status Verified: 2021-10
• Study First Posted: 2021-10-04
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characterisation of lung changes in COVID-19 patients as seen on ultrasound	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

Secondary Outcome Measures

Name	Time	Method
Correlation of lung changes as seen on ultrasound with clinical severity as per the Berlin ARDS criteria	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

Trial Locations

Locations (1)

Chelsea and Westminster Hospital; 🇬🇧 London, Greater London, United Kingdom