Clinical trial NCT04327674: The Use of Focused Lung Ultrasound in Patients Suspected of COVID-19
Official title: The Use of Focused Lung Ultrasound in Patients Suspected of COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 417
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who have symptoms on COVID-19 and is seen at a hospital.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Mechanical Ventilation
timeFrame: During admission, an average of 1 day
Secondary outcomes:
measure: FLUS Findings and Admission to Intensive Care.
timeFrame: During admission, an average of 1 day
measure: SAR-CoV-2 PCR-test Result.
timeFrame: During admission, an average of 1 day
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Lungemedicinsk Forskningsafdeling. Aarhus University Hospital
city: Horsens
country: Denmark
facility: Regionshospitalet Horsens.
Study officials:
affiliation: Aarhus Universitets Hospital
name: Søren H Skaarup
role: PRINCIPAL_INVESTIGATOR
References: