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临床试验/NCT04689672
NCT04689672Unknown不适用

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

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2020年12月16日最近更新:
适应症

试验速览

阶段
不适用
入组人数
600
试验地点
1
主要终点
Patients' short-term outcome

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • impossibility to perform lung ultrasound due to technical limitations.

结局指标

主要结局

Patients' short-term outcome

时间窗: 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).

次要结局

  • Patients' long-term outcome(30 days after access to the Emergency Departement)
  • Intensity of care(Up to 7 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paola Maffi

Associate Professor in Internal Medicine; Head of School of Emergency Medicine

IRCCS San Raffaele

研究点 (1)

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