NCT04393402

Brief Summary

It might be necessary with Sars-Cov2 pneumopathy patient to repeat thoracic images, the tomodensitometry ones in particular. This task is difficult and nearly impossible for several reasons: respiratory and hemodynamic unstable patient, prone position and due to the high contagious nature of the disease. The lung ultrasound is an easy tool, fast (between 5 and 10 minutes) and as a limited training. In the context of the Sars-Cov2 epidemic, Buonsenso and al case report depict the first lung ultrasound for a Covid 19 patient. Peng and al in Intensive Care Medicine accentuate the usefulness of this particular technic. In the American Journal of Respiratory and Critical Care Medicine, a study has been published as a point-of-care, in which the doctors reported using the lung ultrasound with intensive and critical care patient. In Critical Care 2016, it has been showed that ultrasound allowed with neat precisions, to predict severe ARDS patient response to the prone position, all-cause. Another researchers team found a good correlation between lung ultrasound, the SOFA, APACHE II, CPIS score, and patient mortality. And a new applicability in the pulmonary recruitment by PEEP titration has been presented. The aim of this study is to evaluate the lung ultrasound in Covid19 ARDS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Typical duration 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

March 20, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

2.8 years

First QC Date

May 15, 2020

Last Update Submit

April 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • LUS applicability with COVID 19

    In dorsal position, or in prone position, the two hemithorax will be subdivided in 6 parts, and a score will be attributed with the following criteria : A-Lines (0 point), \> 3 B-lines (1 point), B-Lines coalscent (2 points), and pulmonary consolidation (3 points). For the echography we can use a convexe sonde, or a "cardiac" sonde.

    10 months

Secondary Outcomes (3)

  • Radiographic correlation (chest Xray and tomodensitometry)

    10 months

  • LUS Mortality prediction

    10 months

  • Prediction of Prone position response

    10 months

Study Arms (1)

Patients with Covid-19 and admitted in critical care unit

Procedure: lung ultrasound (LUS)

Interventions

Patients with Covid-19 Disease and admitted in critical care unit will be performed a LUS

Patients with Covid-19 and admitted in critical care unit

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with diagnose of Covid 19 by usully method, and admitted in critical care unit for oxygen-therapy or ventilatory support.

You may qualify if:

  • Diagnosed Sars-Cov2 patient, with PCR method qualitative or quantitative as usual.
  • Intensive or critical care admission
  • ARDS with PaO2/FiO2 \<300 at the admission
  • Ventilatory support or oxygen-therapy

You may not qualify if:

  • Age \< 18 years-old
  • Pregnancy
  • Patient with tutor- or curatorship or in prison

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, 06202, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2020

First Posted

May 19, 2020

Study Start

March 20, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

April 10, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

No data sharing plan has been established

Locations