LUS-COVID: Lung Ultrasound in COVID-19 Patients

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)

Overall Status

Recruiting

CT.gov ID

NCT04487769

Collaborator

Centre Hospitalier Universitaire de Brussels, Brussels, Belgium (Other), Miulli Regional Hospital, Acquaviva delle Fonti, Italy (Other), University of Foggia (Other), University of Bari Aldo Moro (Other)

Enrollment

Location

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Covid19 Ultrasound ARDS

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 Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Oct 1, 2021

Outcome Measures

Primary Outcome Measures

Liberation from invasive ventilation [28 days]
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.

Secondary Outcome Measures

Mortality [28 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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