Clinical trial NCT04412551: Lung Ultrasound for Assessment of Patients With Moderate to Severe Covid-19
Official title: Lung Ultrasound for Assessment of Patients With Moderate to Severe Covid-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corona Virus Infection
Virus Diseases
Coronaviridae Infections
Keywords: ultrasonography
lung ultrasound
covid-19
ARDS
Lead sponsor: Dalarna County Council, Sweden
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized adult patients with confirmed Covid-19 and oxygen therapy corresponding to stage 4-5 on the "Ordinal Scale for Clinical Improvement" of the World Health Organization.

Brief summary: This observational study will describe lung ultrasound (LUS) findings over time in hospitalized patients with moderate to severe Covid-19 lung disease. Our primary aim is to investigate if lung ultrasound can identify and/or predict patients requiring mechanical ventilation. Another aim is to describe LUS findings associated with clinical findings and patient condition.

Detailed description: Study patients with moderate to severe Covid-19 infection will be screened with lung ultrasound daily. Lung ultrasound will be assessed by LUS-score for acute respiratory distress syndrome (ARDS) (0-36 points, Bouhemad 2015). Findings of B-line artifacts and consolidations will be noted. In addition to LUS, clinical parameters from physical examination and laboratory tests will be collected. Participants wil be followed until either admission to intensive care unit (ICU) for mechanical ventilation or until clinical improvement. A group of patients with mild Covid-19 infection will be recruited and screened once as reference.

Apart from assessment with LUS, patients are managed according to routine care.

Eligibility criteria: Inclusion Criteria:

* Covid-19 confirmed by positive polymerase chain reaction (PCR)
* oxygen by mask or nasal prongs ≥ 4 l/min or high flow nasal cannula (HFNC) with fraction of inspired oxygen (FiO2) ≥ 30%
* age between 18-80 years
* informed consent

Exclusion Criteria:

* patients subject to treatment-limitation "no ICU"
* history of heart failure
* history of lung disease e.g.: pneumonectomy, pulmonary fibrosis or other interstitial lung disease, pleurodesis
* history of kidney failure requiring dialysis
* any reason making lung ultrasound or daily follow up impossible
* opposition to participation in the study

Primary outcomes:
measure: Identification of requirement of mechanical ventilation
timeFrame: 3 weeks
Secondary outcomes:
measure: Prediction of requirement of mechanical ventilation
timeFrame: 3 weeks
measure: Association of LUS to clinical parameters
timeFrame: 3 weeks
measure: Description of findings on LUS
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Falun
country: Sweden
facility: Falun Hospital
Study officials:
References:
citation: Bouhemad B, Mongodi S, Via G, Rouquette I. Ultrasound for "lung monitoring" of ventilated patients. Anesthesiology. 2015 Feb;122(2):437-47. doi: 10.1097/ALN.0000000000000558. No abstract available.