Predictivity of Hemogasanalysis and Lung UltraSound in Determining COVID-19 Severity

• Conditions: Covid19

• Registration Number: NCT04689672
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

This retrospective-prospective longitudinal observational study was designed to evaluate the role of bedside lung ultrasound per se and in association with hemogasanalysis parameters in predicting the severity of COVID-19 patients in the Emergency Departement (ED).

Retrospective data regarding patients who presented at the ED of IRCCS San Raffaele Hospital from 10/11/2020, together with those acquired by the observation of patients who will access to the ED until 10/05/2021 will be collected, configuring a total enrollment period of 6 months.

Clinical informations about patients' medical history will be recorded, with particular focus on the type and date of onset of the symptoms. The diagnostic and therapeutic strategy will be chosen according to the current standard of care. Results of bedside lung ultrasound, together with vital parameters, blood gas analysis, laboratory and other findings will be recorded.

The primary outcome will be defined as patients' outcome at time of discharge from the ED, in terms of intensity of required care (home discharge, low or high-intensity care hospitalization, death). Secondary outcomes will be patients' prognosis 30 days after access to ED and the required intensity of care (eg need for non-invasive ventilation, oro-tracheal intubation).The follow-up 30 days after access to the ED will be evaluated by telephone survey or by consulting medical records.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-12
• Study Start: 2020-12-16
• Study First Submitted: 2020-12-24
• Study First Submitted QC: 2020-12-28
• Last Update Submitted: 2020-12-28
• Study First Posted: 2020-12-30
• Last Update Posted: 2020-12-30
• Primary Completion: 2021-05-10
• Study Completion: 2021-05-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• SARS - CoV 2 infection confirmed by positive RT-PCR on nasopharyngeal swab

Exclusion Criteria

• impossibility to perform lung ultrasound due to technical limitations.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients' short-term outcome	Up to 7 days	Patients' outcome at time of discharge from the Emergency Departement, expressed in terms of intensity of required care (home discharge, low or high-intensity care hospitalization, death).

Secondary Outcome Measures

Name	Time	Method
Patients' long-term outcome	30 days after access to the Emergency Departement	Patients' outcome 30 days after access to the Emergency Departement, expressed in terms of intensity of required care (home discharge, low or high-intensity care hospitalization, death).
Intensity of care	Up to 7 days	Required intensity of care during the observational period in the Emergency Departement (eg need for non-invasive ventilation, oro-tracheal intubation).

Trial Locations

Locations (1)

IRCCS San Raffaele; 🇮🇹 Milan, MI, Italy