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Lung Ultrasound Score in Covid 19 Infectious Disease in Critical Care (LUS-COVID19) (LUS-COVID19)

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ClinicalTrials.gov Identifier: NCT04393402
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
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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.


Condition or disease Intervention/treatment
COVID Procedure: lung ultrasound (LUS)

Study Design
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Study Type : Observational
Estimated Enrollment : 14 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lung Ultrasound Score in Covid 19 Infectious Disease in Critical Care
Actual Study Start Date : March 20, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with Covid-19 and admitted in critical care unit Procedure: lung ultrasound (LUS)
Patients with Covid-19 Disease and admitted in critical care unit will be performed a LUS


Outcome Measures
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Primary Outcome Measures :
  1. LUS applicability with COVID 19 [ Time Frame: 10 months ]
    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.


Secondary Outcome Measures :
  1. Radiographic correlation (chest Xray and tomodensitometry) [ Time Frame: 10 months ]
    Comparison between Xray / CT scan exam and LUS

  2. LUS Mortality prediction [ Time Frame: 10 months ]
    according to LUS score, ventilatory mode and parameters, medical history and bood analysis results

  3. Prediction of Prone position response [ Time Frame: 10 months ]
    comparison of LUS score depending of the position used for performing LUS


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Age < 18 years-old
  • Pregnancy
  • Patient with tutor- or curatorship or in prison
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04393402


Contacts
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Contact: Jean DELLAMONICA, MD, PhD +334 92 03 55 10 dellamonica.j@chu-nice.fr
Contact: Romain LOMBARDI +336 69 03 26 16 lombardi.r@chu-nice.fr

Locations
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France
CHU de Nice Recruiting
Nice, France, 06202
Contact: Jean DELLAMONICA    +334 92 03 55 10    dellamonica.j@chu-nice.fr   
Contact: Romain LOMBARDI       lombardi.r@chu-nice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT04393402    
Other Study ID Numbers: 20reamedcovid03
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data sharing plan has been established

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infection