Clinical Trials Directory

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UnknownNCT04689672

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

Predictivity of hEmoGasAnalysis Associated to Bedside Lung UltraSound in Determining COVID-19 Severity in the Emergency Departement

Status
Unknown
Phase
Study type
Observational
Enrollment
600 (estimated)
Sponsor
IRCCS San Raffaele · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTLung ultrasoundBedside lung ultrasound

Timeline

Start date
2020-12-16
Primary completion
2021-05-10
Completion
2021-05-10
First posted
2020-12-30
Last updated
2020-12-30

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04689672. Inclusion in this directory is not an endorsement.