Lung Ultrasound in COVID-19 Patients

Covid19 Clinical Trial

— LUS-COVID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04487769
• Other study ID #: LUS-COVID
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: October 2024

Study information

• Verified date: July 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Charalampos Pierrakos, MD
• Phone: +3224772111
• Email: charalampos.pierrakos[@]chu-brugmann.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2024
• Est. primary completion date: August 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ARDS
• COVID-19
• Covid19
• Ultrasound

Locations

Country	Name	City	State
Netherlands	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Amsterdam

Sponsors (5)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Centre Hospitalier Universitaire de Brussels, Brussels, Belgium, Miulli Regional Hospital, Acquaviva delle Fonti, Italy, University of Bari Aldo Moro, University of Foggia

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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