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Completed

NCT Number: NCT04327674

The Use of Focused Lung Ultrasound in Patients Suspected of COVID-19

COVID is a major health problem causing massive capacity problems at hospitals. Rapid and accurate diagnostic workflow is of paramount importance. Access to radiological diagnostics tools such as x-ray or computed tomography of the chest are limited even in high-resource settings.

Focused lung ultrasound, FLUS, is a point-of-care diagnostic tool that allows rapid and on-site assessment of lung abnormalities. No transportation of the patient is required thus lowering risk of spreading SAR-CoV- inside the hospital.

This study aims to explore the diagnostic value of FLUS in the COVID-19 pandemic and to explore if FLUS findings can predict risk of respiratory failure.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lungemedicinsk Forskningsafdeling. Aarhus University Hospital, Aarhus, Denmark

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About this study

COVID-19 is defined as an infectious disease caused by SAR-CoV-2 virus. It results in pneumonia and sometimes respiratory failure. SARS-CoV-2 pandemic has led to massive strain on health care facilities. A large proportion of the population is at risk of COVID-19 and some estimates suggest that up to 15% will need hospitalization. Such number of patients strains the health care system to its maximum as capacity has limitations even in highly developed countries.

Early reports estimate that more than 80% of patients admitted to hospital with COVID-19 have abnormal findings on chest radiographs1. Thus, imaging seems to be an important part of the diagnostic work-up. In most hospitals however, access to CT-scanning of the thorax of all patients with COVID-19 or with suspicion of CODIV-19 is unrealistic due to restricted capacity. Chest radiographs are faster and easier to do, but may require transportation of the patient to the department of radiology which carries a risk of virus spreading in the hospital. On-site chest radiograph is often of such low quality that diagnosis or follow-up will be difficult.

Focused ultrasound examination of the lungs, FLUS, is a diagnostic tool that can show changes in the lung parenchyma due to pneumonia. FLUS is a bed-side examination performed by the physician which results in reduced risk of in-hospital virus contamination. Furthermore, results from FLUS are immediately available to the physician. This allows rapid decision-making which is essential in cases of high patient burdens as seen in the COVID-19 pandemic.

Furthermore, SARS-CoV-2 positive patients with pneumonia may be at higher risk of respiratory failure than those without pneumonia. Identifying patients at high risk can qualify decisions about monitoring level and organization of intensive care resources. Conversely, patient with COVID-19 symptoms but without pneumonic FLUS finding could likely be managed as out-patients. Such a risk-stratification may optimize the allocation of limited healthcare resources and reserve in-hospital capacity to those patients who needs it.

Hypothesis:

FLUS can risk-stratify patients with COVID-19 symptoms. FLUS can predict respiratory failure in patients with COVID-19 pneumonia. FLUS can diagnose COVID-19 pneumonia with high sensitivity and specificity using PCR-test and chest radiograph as reference.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical suspicion of COVID-19 requiring contact to a hospital.

Exclusion criteria

  • Age less than 18 years
  • Previous enrollment in this study.

Treatment and study plan

Primary outcomes

  1. Mechanical Ventilation

    Time frame: During admission, an average of 1 day

    Number of patients on mechanical ventilation.

Secondary outcomes

  1. FLUS Findings and Admission to Intensive Care.

    Time frame: During admission, an average of 1 day

    Intensive care admissions

  2. SAR-CoV-2 PCR-test Result.

    Time frame: During admission, an average of 1 day

    Positive SAR-CoV-2 PCR-test

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 31, 2020
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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