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

Sponsor

Dalarna County Council, Sweden (Other)

Overall Status

Completed

CT.gov ID

NCT04412551

Collaborator

(none)

Enrollment

Location

7.4

Actual Duration (Months)

9.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Corona Virus Infection Virus Diseases Coronaviridae Infections

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

72 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 20, 2020

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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