Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04412551
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Maria Hårdstedt, 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.

Condition or disease
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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Weeks
Official Title: Lung Ultrasound for Assessment of Patients With Moderate to Severe Covid-19
Actual Study Start Date : May 20, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Hospitalized adult patients with confirmed Covid-19 and oxygen therapy corresponding to stage 4-5 on the "Ordinal Scale for Clinical Improvement" of the World Health Organization.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04412551


Contacts
Layout table for location contacts
Contact: Maria Hårdstedt, MD/PhD +46-738089464 maria.hardstedt@regiondalarna.se

Locations
Layout table for location information
Sweden
Falun Hospital Recruiting
Falun, Sweden
Contact: Maria Hårdstedt, PhD         
Sponsors and Collaborators
Dalarna County Council, Sweden
Publications:
Layout table for additonal information
Responsible Party: Maria Hårdstedt, Dr. Maria Hårdstedt, PhD, Specialist Internal Medicine, Dalarna County Council, Sweden
ClinicalTrials.gov Identifier: NCT04412551    
Other Study ID Numbers: LUS-Covid001
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Hårdstedt, Dalarna County Council, Sweden:
ultrasonography
lung ultrasound
covid-19
ARDS
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Virus Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases