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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04412551

Enrollment

Registered

2020-06-02

Start date

2020-05-20

Completion date

2020-12-31

Last updated

2021-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronaviridae Infections, Corona Virus Infection, Virus Diseases

Keywords

ultrasonography, lung ultrasound, covid-19, ARDS

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Sweden

Outcome results