The ECOVITA Study - Validation of LUS Score in SARS-CoV-2 Disease, i.e COVID-19
- Conditions
- Respiratory Distress Syndrome
- Interventions
- Diagnostic Test: lung ultrasound
- Registration Number
- NCT04871685
- Lead Sponsor
- University of Campania "Luigi Vanvitelli"
- Brief Summary
Lung Ultrasound (LUS) has been revealing an extremely useful tool to identify and monitor complications from Sars-COV-2 disease. Recently, a research group has proposed a score, named LUS Score, able to optimize the use of this diagnostic technique. LUS Score is computed analyzing chest posterior and lateral spaces, considering the number of artefacts generated by the inflammed interstitium (B lines), the characteristics of the pleural line and the presence or not of consolidation areas.
The comparison between LUS and chest tomography (CT), the current gold standard for the diagnosis of interstitial pneumonia by COVID-19, has confirmed from the preliminary data, the reliability of such technique. Hence, the validation on a really large sample size of the ultrasound tool performed by dedicated personnel with high expertise, may allow the validation both in the clinical practice and in emergency and ordinary wards.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 950
- men and women;
- confirmed COVID19 diagnosis after nasal-oropharyngeal swab;
- any symptom at hospitalization
- any therapy
- any pre-existing comorbidity
- pregnant women
- healthy subjects with other respiratory diseases different from COVID-19
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Covid Center Cotugno Hospital, Naples lung ultrasound Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units Covid Center Santa Maria delle Grazie Hospital, Pozzuoli lung ultrasound Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units Covid Center Melfi Hospital lung ultrasound Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units Covid Center Vannini Hospital, Rome lung ultrasound Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units Covid Center Messina University Hospital lung ultrasound Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units Covid Center UOC Vanvitelli, Naples lung ultrasound Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units Covid Center "Del Mare Hospital", Naples lung ultrasound Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units Covid Center Monaldi Hospital, Naples lung ultrasound Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units Covid Center Bassini Hospital, ASST Milano Nord lung ultrasound Patients hospitalized due to Sars-Cov-2 disease either in emergency or ordinary medicine/intensive care units
- Primary Outcome Measures
Name Time Method validation of lung ultrasound score 6 months validation of lung ultrasound in the clinical practice of diagnosis of complications of low respiratory tracts during COVID-19
- Secondary Outcome Measures
Name Time Method Association of LUS score with clinical outcome 6 months assessment of LUS score association with the clinical course of disease (final outcome, either discharged or in-hospital mortality
Association of LUS score with duration of hospitalization (days) 6 months assessment of LUS score association with hospitalization days
Association of LUS score with respiratory support required 6 months assessment of LUS score association with requirement of either sub-intensive or intensive therapy)
Trial Locations
- Locations (1)
University of Campania Luigi Vanvitelli
🇮🇹Naples, Campania, Italy