NCT04487769

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

July 24, 2020

Last Update Submit

July 29, 2024

Conditions

Keywords

new coronavirus diseasecoronavirus disease 2019lung imaginglung ultrasoundlung ultrasound scoreprognosticationduration of ventilationmortality

Outcome Measures

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.

    28 days

Secondary Outcomes (1)

  • Mortality

    28 days

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Amsterdam, Netherlands

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Marcus J Schultz, MD

    Amsterdam University Medical Centers, location 'AMC'

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. M.J. Schultz, MD, PhD

Study Record Dates

First Submitted

July 24, 2020

First Posted

July 27, 2020

Study Start

June 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

July 31, 2024

Record last verified: 2024-07

Locations