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

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

Tracking Information

• First Submitted Date: May 15, 2020
• First Posted Date: May 19, 2020
• Last Update Posted Date: May 19, 2020
• Actual Study Start Date: March 20, 2020
• Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 18, 2020)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: May 18, 2020)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Lung Ultrasound Score in Covid 19 Infectious Disease in Critical Care (LUS-COVID19)
• Official Title: Lung Ultrasound Score in Covid 19 Infectious Disease in Critical Care

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: COVID

Intervention

Procedure: lung ultrasound (LUS)

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

Study Groups/Cohorts

Patients with Covid-19 and admitted in critical care unit

Intervention: Procedure: lung ultrasound (LUS)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 18, 2020): 14
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2020
• Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 95 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04393402
• Other Study ID Numbers: 20reamedcovid03
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: No data sharing plan has been established

• Responsible Party: Centre Hospitalier Universitaire de Nice
• Study Sponsor: Centre Hospitalier Universitaire de Nice
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Centre Hospitalier Universitaire de Nice
• Verification Date: May 2020