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CompletedNCT04487769LUS-COVIDUpdated Jul 31, 2024

Lung Ultrasound in COVID-19 Patients

An observational study in Covid19, Ultrasound and ARDS, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-31.

Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
137
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Covid19
  • Ultrasound
  • ARDS

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Keywords

  • new coronavirus disease
  • coronavirus disease 2019
  • lung imaging
  • lung ultrasound
  • lung ultrasound score
  • prognostication
  • duration of ventilation
  • mortality
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 137 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 512 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Severe COVID-19 infection under invasive ventilation who received lung ultrasound examination as a standard care.

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

Exclusion Criteria:

  • Age \<18 years
  • First examination with LUS in patients already under extracorporeal membrane oxygenation (ECMO) support.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
137 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Liberation from invasive ventilation

    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.

    Time frame: 28 days

Secondary outcomes

  1. Mortality

    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.

    Time frame: 28 days

07

Study locations

1 site
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    Amsterdam, Netherlands
08

References and documents

Publications

  • 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. PubMed 34662857 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04487769
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Centre Hospitalier Universitaire de Brussels, Brussels, Belgium, Miulli Regional Hospital, Acquaviva delle Fonti, Italy, University of Foggia, University of Bari Aldo Moro
Responsible party
Prof. Dr. Marcus J. Schultz (Prof. M.J. Schultz, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)) — Principal investigator
First posted
Jul 27, 2020
Start date
Jun 1, 2020
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Last update
Jul 31, 2024

Study contacts

Marcus J Schultz, MD
principal investigator · Amsterdam University Medical Centers, location 'AMC'

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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