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OpenTrials
Completed

NCT Number: NCT04487769

Lung Ultrasound in COVID-19 Patients

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Amsterdam, Netherlands

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Liberation from invasive ventilation

    Time frame: 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 outcomes

  1. Mortality

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

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

Registry information

Official study title

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

Acronym: LUS-COVID

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2020
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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