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Completed

NCT Number: NCT04412551

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Identification of requirement of mechanical ventilation

    Time frame: 3 weeks

    Assessment of LUS-score or findings of consolidations correlated to requirement of mechanical ventilation on ICU

Secondary outcomes

  1. Prediction of requirement of mechanical ventilation

    Time frame: 3 weeks

    Assessment if LUS-score or findings of consolidations is able to anticipate clinical deterioration with requirement of mechanical ventilation on ICU

  2. Association of LUS to clinical parameters

    Time frame: 3 weeks

    Descriptive assessment of clinical parameters and LUS-score over time

  3. Description of findings on LUS

    Time frame: 3 weeks

    Description of quality and distribution pattern of LUS-findings in patients with different severities of Covid-19

Sponsors and collaborators

Lead sponsor

Dalarna County Council, Sweden

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 2, 2020
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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