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

NCT ID: NCT05065827

Last Updated: 2021-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-29

Study Completion Date

2020-12-12

Brief Summary

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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

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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.

Conditions

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Covid19 Coronavirus Corona Virus Infection SARS-CoV Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Normal oxygenation

Normal oxygenation based on the BERLIN criteria for ARDS

No interventions assigned to this group

Mild deficit in oxygenation

Mild deficit in oxygenation based on the BERLIN criteria for ARDS

No interventions assigned to this group

Moderate deficit in oxygenation

Moderate deficit in oxygenation based on the BERLIN criteria for ARDS

No interventions assigned to this group

Severe deficit in oxygenation

Severe deficit in oxygenation based on the BERLIN criteria for ARDS

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chelsea and Westminster NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paramjeet Deol, MBChB FRCEM

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Chelsea and Westminster Hospital

London, Greater London, United Kingdom

Site Status

Countries

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United Kingdom

References

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Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

Reference Type BACKGROUND
PMID: 31986264 (View on PubMed)

Lichtenstein D, Meziere G, Biderman P, Gepner A, Barre O. The comet-tail artifact. An ultrasound sign of alveolar-interstitial syndrome. Am J Respir Crit Care Med. 1997 Nov;156(5):1640-6. doi: 10.1164/ajrccm.156.5.96-07096.

Reference Type BACKGROUND
PMID: 9372688 (View on PubMed)

Lichtenstein D. Lung ultrasound in the critically ill. Curr Opin Crit Care. 2014 Jun;20(3):315-22. doi: 10.1097/MCC.0000000000000096.

Reference Type BACKGROUND
PMID: 24758984 (View on PubMed)

Lichtenstein DA. Current Misconceptions in Lung Ultrasound: A Short Guide for Experts. Chest. 2019 Jul;156(1):21-25. doi: 10.1016/j.chest.2019.02.332. Epub 2019 Mar 11. No abstract available.

Reference Type BACKGROUND
PMID: 30872018 (View on PubMed)

Soldati G, Smargiassi A, Inchingolo R, Buonsenso D, Perrone T, Briganti DF, Perlini S, Torri E, Mariani A, Mossolani EE, Tursi F, Mento F, Demi L. On Lung Ultrasound Patterns Specificity in the Management of COVID-19 Patients. J Ultrasound Med. 2020 Nov;39(11):2283-2284. doi: 10.1002/jum.15326. Epub 2020 May 8. No abstract available.

Reference Type BACKGROUND
PMID: 32383781 (View on PubMed)

Vetrugno L, Bove T, Orso D, Barbariol F, Bassi F, Boero E, Ferrari G, Kong R. Our Italian experience using lung ultrasound for identification, grading and serial follow-up of severity of lung involvement for management of patients with COVID-19. Echocardiography. 2020 Apr;37(4):625-627. doi: 10.1111/echo.14664. Epub 2020 Apr 15.

Reference Type BACKGROUND
PMID: 32239532 (View on PubMed)

Volpicelli G, Gargani L. Sonographic signs and patterns of COVID-19 pneumonia. Ultrasound J. 2020 Apr 21;12(1):22. doi: 10.1186/s13089-020-00171-w.

Reference Type BACKGROUND
PMID: 32318891 (View on PubMed)

Xing C, Li Q, Du H, Kang W, Lian J, Yuan L. Lung ultrasound findings in patients with COVID-19 pneumonia. Crit Care. 2020 Apr 28;24(1):174. doi: 10.1186/s13054-020-02876-9. No abstract available.

Reference Type BACKGROUND
PMID: 32345353 (View on PubMed)

Yasukawa K, Minami T. Point-of-Care Lung Ultrasound Findings in Patients with COVID-19 Pneumonia. Am J Trop Med Hyg. 2020 Jun;102(6):1198-1202. doi: 10.4269/ajtmh.20-0280.

Reference Type BACKGROUND
PMID: 32333544 (View on PubMed)

Soldati G, Smargiassi A, Inchingolo R, Buonsenso D, Perrone T, Briganti DF, Perlini S, Torri E, Mariani A, Mossolani EE, Tursi F, Mento F, Demi L. Proposal for International Standardization of the Use of Lung Ultrasound for Patients With COVID-19: A Simple, Quantitative, Reproducible Method. J Ultrasound Med. 2020 Jul;39(7):1413-1419. doi: 10.1002/jum.15285. Epub 2020 Apr 13.

Reference Type BACKGROUND
PMID: 32227492 (View on PubMed)

Ferguson ND, Fan E, Camporota L, Antonelli M, Anzueto A, Beale R, Brochard L, Brower R, Esteban A, Gattinoni L, Rhodes A, Slutsky AS, Vincent JL, Rubenfeld GD, Thompson BT, Ranieri VM. The Berlin definition of ARDS: an expanded rationale, justification, and supplementary material. Intensive Care Med. 2012 Oct;38(10):1573-82. doi: 10.1007/s00134-012-2682-1. Epub 2012 Aug 25.

Reference Type BACKGROUND
PMID: 22926653 (View on PubMed)

Other Identifiers

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IRAS number 286642

Identifier Type: OTHER

Identifier Source: secondary_id

C&W20/050

Identifier Type: -

Identifier Source: org_study_id