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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前：Pierachille Santus, MD, PhD
- 電話番号：+390239042801
- メール：pierachille.santus@unimi.it
研究連絡先のバックアップ
- 名前：Elisa Franceschi, MD
- 電話番号：+390239042277
- メール：elisa.franceschi@unimi.it
研究場所
-
-
Lombardia
-
Milan、Lombardia、イタリア、20157
- 募集
- Luigi Sacco University Hospital
-
副調査官：
- Elisa Franceschi, MD
-
副調査官：
- Dejan Radovanovic, MD
-
主任研究者：
- Pierachille Santus, MD PhD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Coronavirus Infection
All patients admitted to the Respiratory Unit with SARS-CoV-2 infection and respiratory failure
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Real life data of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
時間枠：1-6 months
|
Data collection about the real life management of patients affected by SARS-CoV-2 infection with acute respiratory distress syndrome
|
1-6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
in-hospital mortality
時間枠：1 month
|
How many patients died during the hospitalization
|
1 month
|
|
30 days mortality
時間枠：1 month
|
How many patients died 30 days after the discharge
|
1 month
|
|
6 months mortality
時間枠：6 months
|
How many patients died 6 months after the discharge
|
6 months
|
|
Intubation rate
時間枠：7 days
|
How many patients were intubated during the hospitalization
|
7 days
|
|
Time to Intubation
時間枠：7 days
|
How many days/hours from admittance to intubation
|
7 days
|
|
Time to ventilation
時間枠：7 days
|
How many days/hours from admittance to the start of non invasive ventilation or CPAP therapy
|
7 days
|
|
Non invasive to Invasive time
時間枠：7 days
|
How many days/hours from the start of non invasive ventilation or CPAP therapy to the intubation
|
7 days
|
|
Recovery rate
時間枠：1 month
|
How many patients were healed from the infection and discharged
|
1 month
|
|
Recurrence rate
時間枠：1 month
|
How many patients underwent re-infection after previous recovery from COVID19
|
1 month
|
|
Risk factor for COVID19
時間枠：retrospective
|
Assessment of the risk factors for the infection and the admission to the hospital
|
retrospective
|
|
Blood tests and outcome
時間枠：1 month
|
What serological parameter could be used as predictor of good or negative prognosis.
|
1 month
|
|
Antiviral therapy
時間枠：1 month
|
Impact of antiviral therapy on the clinical course of the disease
|
1 month
|
|
Coinfections
時間枠：1 month
|
Assessment of bacterial, fungal or other coinfections rate
|
1 month
|
|
Radiological findings
時間枠：1 month
|
Impact of radiological findings on the clinical course and the outcome
|
1 month
|
|
Ultrasound findings
時間枠：1 month
|
Impact of ultrasound findings on the clinical course and the outcome
|
1 month
|
|
Myocardial injury
時間枠：1 month
|
Assessment of the evidence of myocardial injury in covid19+ patients
|
1 month
|
|
Medical management
時間枠：1 month
|
impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course.
|
1 month
|
協力者と研究者
スポンサー
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 17263/2020
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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