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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04393402
Other study ID # 20reamedcovid03
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 20, 2020
Est. completion date December 31, 2020

Study information

Verified date May 2020
Source Centre Hospitalier Universitaire de Nice
Contact Jean DELLAMONICA, MD, PhD
Phone +334 92 03 55 10
Email dellamonica.j@chu-nice.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 14
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 95 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
lung ultrasound (LUS)
Patients with Covid-19 Disease and admitted in critical care unit will be performed a LUS

Locations

Country Name City State
France CHU de Nice Nice

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

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