Lung Ultrasound for Assessment of Patients With Moderate to Severe Covid-19

Completed

• Conditions: Corona Virus Infection; Virus Diseases; Coronaviridae Infections

• Registration Number: NCT04412551
• Lead Sponsor: Dalarna County Council, Sweden

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.

Study Timeline

• Study Start: 2020-05-20
• Study First Submitted: 2020-06-01
• Study First Submitted QC: 2020-06-01
• Study First Posted: 2020-06-02
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-17
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of requirement of mechanical ventilation	3 weeks	Assessment of LUS-score or findings of consolidations correlated to requirement of mechanical ventilation on ICU

Secondary Outcome Measures

Name	Time	Method
Prediction of requirement of mechanical ventilation	3 weeks	Assessment if LUS-score or findings of consolidations is able to anticipate clinical deterioration with requirement of mechanical ventilation on ICU
Association of LUS to clinical parameters	3 weeks	Descriptive assessment of clinical parameters and LUS-score over time
Description of findings on LUS	3 weeks	Description of quality and distribution pattern of LUS-findings in patients with different severities of Covid-19

Trial Locations

Locations (1)

Falun Hospital; 🇸🇪 Falun, Sweden