NCT04327674

Brief Summary

COVID is a major health problem causing massive capacity problems at hospitals. Rapid and accurate diagnostic workflow is of paramount importance. Access to radiological diagnostics tools such as x-ray or computed tomography of the chest are limited even in high-resource settings. Focused lung ultrasound, FLUS, is a point-of-care diagnostic tool that allows rapid and on-site assessment of lung abnormalities. No transportation of the patient is required thus lowering risk of spreading SAR-CoV- inside the hospital. This study aims to explore the diagnostic value of FLUS in the COVID-19 pandemic and to explore if FLUS findings can predict risk of respiratory failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
417

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

March 14, 2020

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
4 years until next milestone

Results Posted

Study results publicly available

June 10, 2024

Completed
Last Updated

June 10, 2024

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

March 27, 2020

Results QC Date

January 5, 2022

Last Update Submit

June 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mechanical Ventilation

    Number of patients on mechanical ventilation.

    During admission, an average of 1 day

Secondary Outcomes (2)

  • FLUS Findings and Admission to Intensive Care.

    During admission, an average of 1 day

  • SAR-CoV-2 PCR-test Result.

    During admission, an average of 1 day

Eligibility Criteria

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

All patients who have symptoms on COVID-19 and is seen at a hospital.

You may qualify if:

  • Clinical suspicion of COVID-19 requiring contact to a hospital.

You may not qualify if:

  • Age less than 18 years
  • Previous enrollment in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lungemedicinsk Forskningsafdeling. Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Regionshospitalet Horsens.

Horsens, Denmark

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Søren Helbo Skaarup
Organization
Department of Respiratory Diseases and Allergy. Aarhus University Hospital. Denmark.

Study Officials

  • Søren H Skaarup

    Aarhus Universitets Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2020

First Posted

March 31, 2020

Study Start

March 14, 2020

Primary Completion

June 15, 2020

Study Completion

June 15, 2020

Last Updated

June 10, 2024

Results First Posted

June 10, 2024

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations