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

NCT ID: NCT04412551

Last Updated: 2021-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-20

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Corona Virus Infection Virus Diseases Coronaviridae Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dalarna County Council, Sweden

OTHER

Sponsor Role lead

Responsible Party

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Maria Hårdstedt

Dr. Maria Hårdstedt, PhD, Specialist Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Falun Hospital

Falun, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 25501898 (View on PubMed)

Other Identifiers

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LUS-Covid001

Identifier Type: -

Identifier Source: org_study_id

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