Lung Ultrasound in COVID-19 Patients

NCT ID: NCT04487769

Last Updated: 2024-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

137 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Covid19 Ultrasound ARDS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Brussels, Brussels, Belgium

UNKNOWN

Sponsor Role collaborator

Miulli Regional Hospital, Acquaviva delle Fonti, Italy

UNKNOWN

Sponsor Role collaborator

University of Foggia

OTHER

Sponsor Role collaborator

University of Bari Aldo Moro

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Marcus J. Schultz

Prof. M.J. Schultz, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcus J Schultz, MD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam University Medical Centers, location 'AMC'

Locations

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

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 34662857 (View on PubMed)

Other Identifiers

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LUS-COVID

Identifier Type: -

Identifier Source: org_study_id

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