COVID-19
Conditions
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.
Interventions
None listed
Sponsors
University of Aarhus
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Clinical suspicion of COVID-19 requiring contact to a hospital.
Exclusion criteria
* Age less than 18 years * Previous enrollment in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical Ventilation | During admission, an average of 1 day | Number of patients on mechanical ventilation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FLUS Findings and Admission to Intensive Care. | During admission, an average of 1 day | Intensive care admissions |
| SAR-CoV-2 PCR-test Result. | During admission, an average of 1 day | Positive SAR-CoV-2 PCR-test |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FLUS All patients admitted to hospital with symptoms of COVID-19 or PCR confirmed SARS-CoV-2 infection | 398 |
| Total | 398 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 19 |
Baseline characteristics
| Characteristic | FLUS |
|---|---|
| Age, Continuous | 67.8 years STANDARD_DEVIATION 15.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 398 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 189 Participants |
| Sex: Female, Male Male | 209 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 47 / 398 |
| other Total, other adverse events | 0 / 398 |
| serious Total, serious adverse events | 398 / 398 |
Outcome results
Primary
Mechanical Ventilation
Number of patients on mechanical ventilation.
Time frame: During admission, an average of 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FLUS | Mechanical Ventilation | 21 Participants |
Secondary
FLUS Findings and Admission to Intensive Care.
Intensive care admissions
Time frame: During admission, an average of 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FLUS | FLUS Findings and Admission to Intensive Care. | 28 Participants |
Secondary
SAR-CoV-2 PCR-test Result.
Positive SAR-CoV-2 PCR-test
Time frame: During admission, an average of 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FLUS | SAR-CoV-2 PCR-test Result. | 227 Participants |