Lung Ultrasound in COVID-19 Patients

Completed

• Conditions: ARDS; Ultrasound; Covid19

• Registration Number: NCT04487769
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

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

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 Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-07-24
• Study First Submitted QC: 2020-07-24
• Study First Posted: 2020-07-27
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); 🇳🇱 Amsterdam, Netherlands