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

NCT04412551 | Completed

• 1 other identifier: LUS-Covid001
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Corona Virus Infection; Virus Diseases; Coronaviridae Infections

Keywords

ultrasonography; lung ultrasound; covid-19; ARDS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Prediction of requirement of mechanical ventilation

  3 weeks

• Association of LUS to clinical parameters

  3 weeks

• Description of findings on LUS

  3 weeks

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dalarna County Council, Sweden: lead

Study Sites (1)

Falun Hospital

Falun, Sweden

Location

Related Publications (1)

• 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.

  PMID: 25501898 BACKGROUND

MeSH Terms

Conditions

Coronavirus Infections; Virus Diseases; Coronaviridae Infections; COVID-19

Condition Hierarchy (Ancestors)

Nidovirales Infections; RNA Virus Infections; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Maria Hårdstedt, PhD, Specialist Internal Medicine

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 2, 2020
• Study Start: May 20, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)