Acute Respiratory Failure and COVID-19 in Real Life
Acute Respiratory Failure and Continuous Positive Airway Pressure Therapy in Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: a Real Life Evaluation
In December 2019 a new kind of virus was identified in China as the responsible of severe acute respiratory syndrome (SARS) and interstitial pneumonia. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quickly spread around the world and in February 2020 became a pandemia in Europe.
No pharmacological treatment is actually licensed for the SARS-CoV2 infection and at the current state of art there is a lack of data about the clinical management of the coronavirus 2019 disease (COVID-19).
The aim of this observational study is to collect the data and the outcomes of COVID-19 patients admitted in the H. Sacco Respiratory Unit treated according to the Standard Operating Procedures and the Good Clinical Practice.
研究概览
详细说明
All consecutive adult COVID-19 patients admitted to our Respiratory Unit will be enrolled. All demographic, anthropometric, laboratory, radiological, clinical and microbiological data will be collected and analyzed according to the primary and secondary outcomes (see the dedicated section).
During the hospitalization, patients will be treated according to the standard operating procedure of our Respiratory Unit, such as arterial gas analysis, Rx, pharmacological treatment, ventilation. This study is purely observational and no randomization will be performed.
After discharge, patients a 7 days, 30 days and 6 months follow up will be assessed.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Lombardia
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Milan、Lombardia、意大利、20157
- 招聘中
- Luigi Sacco University Hospital
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副研究员：
- Elisa Franceschi, MD
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副研究员：
- Dejan Radovanovic, MD
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首席研究员：
- Pierachille Santus, MD PhD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patients that can give written or oral informed consent
- patients with microbiological diagnosis (i.e. rhinopharyngeal swab) of SARS-CoV2 infection
Exclusion Criteria:
- severe cognitive impairment
- absolute contraindication to non invasive ventilation or cpap therapy
- rhinopharyngeal swab negative for SARS-CoV2
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Coronavirus Infection
All patients admitted to the Respiratory Unit with SARS-CoV-2 infection and respiratory failure
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standard operating procedures represented by continuous positive airway pressure (CPAP) therapy or non invasive ventilation, pharmacological treatment as antiviral and antibiotic drugs, bronchodilators, xanthines, enteral nutrition, hydration.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Real life data of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
大体时间：1-6 months
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Data collection about the real life management of patients affected by SARS-CoV-2 infection with acute respiratory distress syndrome
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1-6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
in-hospital mortality
大体时间：1 month
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How many patients died during the hospitalization
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1 month
|
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30 days mortality
大体时间：1 month
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How many patients died 30 days after the discharge
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1 month
|
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6 months mortality
大体时间：6 months
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How many patients died 6 months after the discharge
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6 months
|
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Intubation rate
大体时间：7 days
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How many patients were intubated during the hospitalization
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7 days
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Time to Intubation
大体时间：7 days
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How many days/hours from admittance to intubation
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7 days
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Time to ventilation
大体时间：7 days
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How many days/hours from admittance to the start of non invasive ventilation or CPAP therapy
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7 days
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Non invasive to Invasive time
大体时间：7 days
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How many days/hours from the start of non invasive ventilation or CPAP therapy to the intubation
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7 days
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Recovery rate
大体时间：1 month
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How many patients were healed from the infection and discharged
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1 month
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Recurrence rate
大体时间：1 month
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How many patients underwent re-infection after previous recovery from COVID19
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1 month
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Risk factor for COVID19
大体时间：retrospective
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Assessment of the risk factors for the infection and the admission to the hospital
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retrospective
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Blood tests and outcome
大体时间：1 month
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What serological parameter could be used as predictor of good or negative prognosis.
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1 month
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Antiviral therapy
大体时间：1 month
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Impact of antiviral therapy on the clinical course of the disease
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1 month
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Coinfections
大体时间：1 month
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Assessment of bacterial, fungal or other coinfections rate
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1 month
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Radiological findings
大体时间：1 month
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Impact of radiological findings on the clinical course and the outcome
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1 month
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Ultrasound findings
大体时间：1 month
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Impact of ultrasound findings on the clinical course and the outcome
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1 month
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Myocardial injury
大体时间：1 month
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Assessment of the evidence of myocardial injury in covid19+ patients
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1 month
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Medical management
大体时间：1 month
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impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course.
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1 month
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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