NCT05065827

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 29, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
Last Updated

October 22, 2021

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

September 30, 2021

Last Update Submit

October 14, 2021

Conditions

Keywords

COVID-19Lung ultrasoundRetrospective

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    2-3 months

Study Arms (4)

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with COVID-19 viral infection.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chelsea and Westminster Hospital

London, Greater London, SW10 9NH, United Kingdom

Location

Related Publications (11)

  • 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.

    PMID: 31986264BACKGROUND
  • 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.

    PMID: 9372688BACKGROUND
  • Lichtenstein D. Lung ultrasound in the critically ill. Curr Opin Crit Care. 2014 Jun;20(3):315-22. doi: 10.1097/MCC.0000000000000096.

    PMID: 24758984BACKGROUND
  • 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.

    PMID: 30872018BACKGROUND
  • 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.

    PMID: 32383781BACKGROUND
  • 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.

    PMID: 32239532BACKGROUND
  • 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.

    PMID: 32318891BACKGROUND
  • 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.

    PMID: 32345353BACKGROUND
  • 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.

    PMID: 32333544BACKGROUND
  • 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.

    PMID: 32227492BACKGROUND
  • 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.

    PMID: 22926653BACKGROUND

MeSH Terms

Conditions

COVID-19Coronavirus InfectionsSevere Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Paramjeet Deol, MBChB FRCEM

    paramjeet.deol@chelwest.nhs.uk

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2021

First Posted

October 4, 2021

Study Start

September 29, 2020

Primary Completion

December 12, 2020

Study Completion

December 12, 2020

Last Updated

October 22, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations