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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05065827
• Other study ID #: C&W20/050
• Secondary ID: IRAS number 2866
• Status: Completed
• Start date: September 29, 2020
• Est. completion date: December 12, 2020

Study information

• Verified date: October 2021
• Source: Chelsea and Westminster NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 12, 2020
• Est. primary completion date: December 12, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Corona Virus Infection
• Coronavirus
• Coronavirus Infections
• COVID-19
• Covid19
• Infections
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Locations

Country	Name	City	State
United Kingdom	Chelsea and Westminster Hospital	London	Greater London

Sponsors (1)

Lead Sponsor	Collaborator
Chelsea and Westminster NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (11)

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. Epub 2012 Aug 25. Erratum in: Intensive Care Med. 2012 Oct;38(10):1731-2. — View Citation

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. Erratum in: Lancet. 2020 Jan 30;:. — View Citation

Lichtenstein D, Mézière G, Biderman P, Gepner A, Barré O. The comet-tail artifact. An ultrasound sign of alveolar-interstitial syndrome. Am J Respir Crit Care Med. 1997 Nov;156(5):1640-6. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterisation of lung changes in COVID-19 patients as seen on ultrasound	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	Correlation of lung changes as seen on ultrasound with clinical severity as per the Berlin ARDS criteria	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