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

Completed
Respiratory Failure
COVID-19
Mechanical Ventilation
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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Argentina
Locations

Hospital Interzonal General de Agudos Gral. San Martín
La Plata, BA, Argentina

Sanatorio Las Lomas
san Isidro, BA, Argentina

Hospital General de Agudos Juan A. Fernández
Buenos Aires, Caba, Argentina

Sanatorio Anchorena Recoleta
Buenos Aires, Caba, Argentina

Sanatorio Otamendi
Buenos Aires, Ciudad Autonoma De Buenos Aires, Argentina

Elisa Estenssoro, MD, Study Chair
Hospital Interzonal de Agudos San Martin de La Plata

Argentinian Intensive Care Society
NCT Number
MeSH Terms
COVID-19
Respiratory Insufficiency