Lung Ultrasound in COVID-19 Patients (LUS-COVID)

Early Lung Ultrasound Score Predicts Duration of Ventilation and ICU Mortality in COVID-19 Invasively Ventilated Patients

To assess the prognostic performance of an early global LUS score with respect to the mortality in ICU and duration of ventilation.

Study Overview

• Status: Completed
• Conditions: Covid19; ARDS; Ultrasound

Detailed Description

This is an international multicenter cohort study on data collected between March and April 2020. The first available lung ultrasound examination that used a 12-regions approach was used to calculate the global LUS score.

Patients are included if they fulfilled the following criteria: 1) admitted to one of the participating ICU; 2) for invasive ventilation; 3) for respiratory failure due to confirmed COVID-19; and 4) having had a LUS examination performed within the first week of start of invasive ventilation.

The primary and secondary outcomes were liberation from invasive ventilation and mortality.

Demographic, clinical and outcome variables will be presented as percentages for categorical variables and as medians with interquartile ranges (IQR) for continuous variables.

Receiver operating characteristics (ROC) analysis will be used to derive the prognostic discriminatory performance of global LUS score in determining succesful extubation and mortality at day 28. The Youden index will be used to derive the optimal cut-off. The association of global LUS with unfavourable outcomes are analyzed with Cox proportional hazard analysis (for successful extubation and alive at day 28), logistic regression models (mortality at day 28). Hazard ratio or odds ratio with 95% confidence intervals were calculated for each outcome.

• Study Type: Observational
• Enrollment (Actual): 137

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Severe COVID-19 infection under invasive ventilation who received lung ultrasound examination as a standard care.

Description

Inclusion Criteria:

• Admitted to an ICU participating in this study between February 1, 2020 and April 30, 2020
• Confirmed with reverse transcriptase polymerase chain reaction (RT-PCR) COVID-19 infection
• Having had received invasive ventilation
• Having had examined at least once with lung ultrasound under invasive ventilation

Exclusion Criteria:

• Age <18 years
• First examination with LUS in patients already under extracorporeal membrane oxygenation (ECMO) support.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liberation from invasive ventilation	Patient who survived but remained invasively ventilated up to day 28 were marked without event. Patients who survived but were extubated were marked with an event at the day of successful extubation.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Patient who survived up to day 28 were marked without event. Patients who survived but were extubated were marked with an event at the day of successful extubation.	28 days

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: University of Bari Aldo Moro; University of Foggia; Centre Hospitalier Universitaire de Brussels, Brussels, Belgium; Miulli Regional Hospital, Acquaviva delle Fonti, Italy
• Investigators: Principal Investigator: Marcus J Schultz, MD, Amsterdam University Medical Centers, location 'AMC'

Publications and helpful links

General Publications

• Pierrakos C, Lieveld A, Pisani L, Smit MR, Heldeweg M, Hagens LA, Smit J, Haaksma M, Veldhuis L, Schmidt RW, Errico G, Marinelli V, Attou R, David CE, Zimatore C, Murgolo F, Grasso S, Mirabella L, Cinnella G, De Bels D, Schultz MJ, Tuinman PR, Bos LD. A Lower Global Lung Ultrasound Score Is Associated with Higher Likelihood of Successful Extubation in Invasively Ventilated COVID-19 Patients. Am J Trop Med Hyg. 2021 Oct 18;105(6):1490-1497. doi: 10.4269/ajtmh.21-0545.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: July 24, 2020
• First Submitted That Met QC Criteria: July 24, 2020
• First Posted (Actual): July 27, 2020

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: mortality; lung ultrasound; coronavirus disease 2019; lung imaging; prognostication; new coronavirus disease; lung ultrasound score; duration of ventilation
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: LUS-COVID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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