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

Lung Ultrasound Score in Covid 19 Infectious Disease in Critical Care

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.

Study Overview

• Status: Unknown
• Conditions: COVID
• Intervention / Treatment: Procedure: lung ultrasound (LUS)

• Study Type: Observational
• Enrollment (Anticipated): 14

Contacts and Locations

• Study Contact: Name: Jean DELLAMONICA, MD, PhD; Phone Number: +334 92 03 55 10; Email: dellamonica.j@chu-nice.fr
• Study Contact Backup: Name: Romain LOMBARDI; Phone Number: +336 69 03 26 16; Email: lombardi.r@chu-nice.fr

Study Locations

• France
  • Nice, France, 06202
    • Recruiting
    • Chu de Nice
    • Contact: Jean DELLAMONICA; Phone Number: +334 92 03 55 10; Email: dellamonica.j@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic correlation (chest Xray and tomodensitometry)	Comparison between Xray / CT scan exam and LUS	10 months
LUS Mortality prediction	according to LUS score, ventilatory mode and parameters, medical history and bood analysis results	10 months
Prediction of Prone position response	comparison of LUS score depending of the position used for performing LUS	10 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 20, 2020
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (ACTUAL): May 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 20reamedcovid03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No data sharing plan has been established

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No