Clinical trial NCT04487769: Lung Ultrasound in COVID-19 Patients
Official title: Early Lung Ultrasound Score Predicts Duration of Ventilation and ICU Mortality in COVID-19 Invasively Ventilated Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Ultrasound
ARDS
Keywords: new coronavirus disease
coronavirus disease 2019
lung imaging
lung ultrasound
lung ultrasound score
prognostication
duration of ventilation
mortality
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Brussels, Brussels, Belgium
name: Miulli Regional Hospital, Acquaviva delle Fonti, Italy
name: University of Foggia
name: University of Bari Aldo Moro
First posted: 2020-07-27
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severe COVID-19 infection under invasive ventilation who received lung ultrasound examination as a standard care.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Liberation from invasive ventilation
timeFrame: 28 days
Secondary outcomes:
measure: Mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study officials:
affiliation: Amsterdam University Medical Centers, location 'AMC'
name: Marcus J Schultz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.