Clinical Characteristics and Outcomes of Patients With COVID-19 on Mechanical Ventilation in Argentina

Study Overview
=================
Brief Summary
-----------------
The main objective of the present study is to determine ICU and in-hospital mortality associated with COVID-19 infection and its independent predictors, in patients admitted to adult ICUs in Argentina with a requirement for mechanical ventilation. Secondary objectives include: determining epidemiological and clinical data in patients with COVID-19 disease; the associated morbidity, the support and therapeutic measures implemented, and the evolution of these patients upon discharge from the ICU. Likewise, characteristics of each ICU will be recorded, and a survey will be carried out on the management of the COVID-19 pandemic, which will require information on the additional availability of critical resources for the care of patients admitted to the ICU. Likewise, characteristics of the ICU and hospitals will be registered.

Detailed Description
-----------------
In December 2019, China reported cases of acute respiratory disease caused by a new beta-coronavirus (SARS-CoV-2), called COVID-19 by the WHO. In January 2020 this entity issues an alert about the emergence of this new disease throughout the world, and in March it declares it a pandemic. Severe cases represent around 14-20% of those reported, and admission to the ICU is highly variable according to the different publications and severity of disease, ranging between 29% and 89%. The mortality reported in these publications ranges between 1.4 and 42%; with the development of acute respiratory distress syndrome (ARDS) being one of the most severe complications, associated with worst outcomes. However, the time of appearance of symptoms of severe acute respiratory failure has shown significant variability between these studies, with a median appearance of 2, 5 and 14 days from the onset of symptoms of the disease. As of March 21, 2020, cases in Latin America were increasing, finding countries such as Brazil, Chile, Ecuador, Peru and Argentina among the countries with the highest number of confirmed cases, being classified as countries with local transmission. Since there is no information about on the behavior of this new disease in our country, the Argentine Society of Intensive Care (SATI) launched an epidemiological study to know the characteristics, risk factors and evolution of the most severely compromised patients with COVID-19, those admitted to the ICU requiring mechanical ventilation (MV). Therefore, the main objective of the present study is to determine the ICU and in-hospital mortality associated with COVID-19 infection and its independent predictors, in patients admitted to adult ICUs in Argentina on MV. Secondary objectives include: determining epidemiological and clinical data and mechanical ventilation management in patients with COVID-19 , support and therapeutic measures implemented by their assistant physicians, and the evolution and complications developed by these patients during their ICU stay. The different causes of death will also be recorded. Likewise, characteristics of each ICU will be recorded, and a survey will be carried out on the management of the COVID-19 pandemic, which will require information on the additional availability of critical resources for the care of patients admitted to the ICU. The opinion about the management of the pandemic by the different governmental strata will be required, in order to detect possible points of improvement in the external management of the pandemic.

Official Title
-----------------
Clinical Characteristics and Outcomes of Patients With COVID-19 on Mechanical Ventilation in Argentina: a Prospective, Multicenter Cohort Study

Conditions
-----------------
Respiratory Failure, Covid-19, Mechanical Ventilation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Consecutive adult patients admitted to participating ICUs who require mechanical ventilation and present confirmed COVID-19 . Exclusion Criteria: Patients with severe respiratory infections / pneumonia due to another proven etiology.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult, patients with COVID-19 admitted to the ICU requiring mechanical ventilation<br>This is a prospective cohort study including patients >18 years RT-PCR positive for SARS Cov-2 admitted to the ICU that require mechanical ventilation. Epidemiological data, comorbidities, previous signs of symptoms of COVID-19. On admission, severity of disease scores, laboratory management data, blood gases and acid-base chemistry,respiratory and mechanical ventilation management,and complications (Development of ARDS, septic shock, acute kidney injury, thromboembolic events, infections and septic shock, will be recorded. If patients die, causes of death will be recorded.Treatments administered by attending physicians will be registered. Dates of hospital and ICU admission, of death and/or discharge will be recorded. No intervention will be administered. Follow-up will continue until death or ICU/hospital discharge | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU Mortality | Refers to patients dying during their stay at the ICU, whatever the cause | From inclusion up to 90 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital mortality | Refers to patients dying in the hospital, whatever the cause, after ICU discharge | From date of inclusion to date of death from any cause, assessed up to 90 days |