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.

Study Overview

• Status: Completed
• Conditions: Coronaviridae Infections; Virus Diseases; Corona Virus Infection

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 Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• Sweden
  • Falun, Sweden
    • Falun hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of requirement of mechanical ventilation	Assessment of LUS-score or findings of consolidations correlated to requirement of mechanical ventilation on ICU	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction of requirement of mechanical ventilation	Assessment if LUS-score or findings of consolidations is able to anticipate clinical deterioration with requirement of mechanical ventilation on ICU	3 weeks
Association of LUS to clinical parameters	Descriptive assessment of clinical parameters and LUS-score over time	3 weeks
Description of findings on LUS	Description of quality and distribution pattern of LUS-findings in patients with different severities of Covid-19	3 weeks

Collaborators and Investigators

• Sponsor: Dalarna County Council, Sweden

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 20, 2020
• Primary Completion (ACTUAL): December 31, 2020
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: June 1, 2020
• First Submitted That Met QC Criteria: June 1, 2020
• First Posted (ACTUAL): June 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 17, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: ARDS; lung ultrasound; covid-19; ultrasonography
• Additional Relevant MeSH Terms: Pathologic Processes; Nidovirales Infections; RNA Virus Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Coronavirus Infections; Infections; Communicable Diseases; Virus Diseases; Coronaviridae Infections
• Other Study ID Numbers: LUS-Covid001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No