Mechanical Ventilation Epidemiology in Argentina. (EpVAr2019)
October 21, 2020 updated by: Gustavo Plotnikow, Argentinian Intensive Care Society
Mechanical Ventilation Epidemiology in Argentina. EpVAr Multicenter Study.
How is the epidemiology of mechanically ventilated patients in the intensive care units of Argentina?
Study Overview
Status
Completed
Conditions
Detailed Description
Mechanical ventilation is an indispensable tool in life support and one of the interventions that characterizes intensive care units (ICU).
Epidemiological studies have allowed us to improve knowledge and optimize the treatment of patients with acute respiratory failure.
In Latin America the epidemiological data of mechanical ventilation is poor.
Primary goal of this national, observational, prospective, multicentric epidemiological study: to analyze the survival and describe epidemiological features of patients receiving mechanical ventilation in the Intensive Care Units of Argentina.
Study Type
Observational
Enrollment (Actual)
950
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Avellaneda, Argentina
- Hospital Fiorito
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Avellaneda, Argentina
- Sanatorio Norte SRL
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Bahía Blanca, Argentina
- Hospital Italiano Regional del Sur
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Bahía Blanca, Argentina
- Hospital privado Dr Raul Matera
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Bariloche, Argentina
- Hospital Area Programa Bariloche "Ramón Carrillo"
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Buenos AIres, Argentina
- Hospital Sírio Libanês
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Buenos AIres, Argentina
- Hospital Universitario UAI
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Buenos Aires, Argentina
- Hospital Italiano de Buenos Aires
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Buenos Aires, Argentina
- Hospital Aleman
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Buenos Aires, Argentina
- Clínica Bazterrica
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Buenos Aires, Argentina
- HOSPITAL DE CLINICAS JOSE DE SAN MARTIN
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Buenos Aires, Argentina
- Instituto Argentino de Diagnostico y Tratamiento
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Buenos Aires, Argentina
- Hospital Fernandez
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Buenos Aires, Argentina
- Hospital Santojanni
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Buenos Aires, Argentina
- Sanatorio Anchorena
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Buenos Aires, Argentina
- Sanatorio de los Arcos
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Buenos Aires, Argentina
- Sanatorio Mater Dei
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Buenos Aires, Argentina
- Sanatorio de la Trinidad Mitre
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Buenos Aires, Argentina
- Clinica Adventista Belgrano
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Buenos Aires, Argentina
- Hospital Ramos Mejia
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Buenos Aires, Argentina
- Cemic H.U. Pombo
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Buenos Aires, Argentina
- CEMIC H.U. Saavedra
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Buenos Aires, Argentina
- Clínica La Sagrada Familia
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Buenos Aires, Argentina
- Clínica y Maternidad Suizo Argentina
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Buenos Aires, Argentina
- Clínica Zabala
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Buenos Aires, Argentina
- Clínica Pasteleros
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Buenos Aires, Argentina
- Complejo Medico de la Policia Federal Churruca Visca
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Buenos Aires, Argentina
- Cínica de los Virreyes
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Buenos Aires, Argentina
- Hospital Alvarez
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Buenos Aires, Argentina
- Hospital de Rehabilitación Respiratoria María Ferrer
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Buenos Aires, Argentina
- Hospital de Trauma y Emergencia Dr. Federico Abete
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Buenos Aires, Argentina
- Hospital Dr D. Velez Sarsfield
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Buenos Aires, Argentina
- Hospital Francisco Javier Muñiz
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Buenos Aires, Argentina
- Hospital Generall de Agudos Dr Cosme Argerich
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Buenos Aires, Argentina
- Hospital Naval Pedro Mallo
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Buenos Aires, Argentina
- Hospital Piñero
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Buenos Aires, Argentina
- Hospital Santojanni SRS
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Buenos Aires, Argentina
- Hospital Universitario Fundación Favaloro-UTI 1
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Buenos Aires, Argentina
- Hospital Universitario Fundación Favaloro-UTI 2
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Buenos Aires, Argentina
- HZGA Dr alberto Balestrini
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Buenos Aires, Argentina
- Instituto de Trasplante y Alta Complejidad
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Buenos Aires, Argentina
- Instituto Lanari
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Buenos Aires, Argentina
- Instituto Médico de Alta Complejidad
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Buenos Aires, Argentina
- Sanatorio Colegiales
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Buenos Aires, Argentina
- Sanatorio de la Trinidad Palermo
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Buenos Aires, Argentina
- Sanatorio Finochietto
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Buenos Aires, Argentina
- Sanatorio Otamendi
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Carmen de Patagones, Argentina
- Hospital Municipal de Agudos Dr. Pedro Ecay
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Cañuelas, Argentina
- Htal de alta complejidad cuenca alta SAMIC
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Chacabuco, Argentina
- Hospital Municipal del Carmen de Chacabuco
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Chivilcoy, Argentina
- Hospital de Chivilcoy
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Cipolletti, Argentina
- Policlinico Modelo Cipolletti
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Ciudadela, Argentina
- Hospital Carrillo de Ciudadela
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Comodoro Rivadavia, Argentina
- Clinica del Valle
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Comodoro Rivadavia, Argentina
- Hospital Regional V Sanguinetti
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Comodoro Rivadavia, Argentina
- Hospital Zonal Alvear
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Concepción Del Uruguay, Argentina
- Hospital Justo José de Urquiza
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Cordoba, Argentina
- Hospital Privado de Cordoba
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Cordoba, Argentina
- Clinica Chutro
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Cordoba, Argentina
- Clínica Santa María
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Cordoba, Argentina
- Clinica Universitaria Reina Fabiola
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Cordoba, Argentina
- Hospital Italiano
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Cordoba, Argentina
- Hospital Misericordia Nuevo Siglo
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Cordoba, Argentina
- Hospital San Roque
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Cordoba, Argentina
- Sanatorio Allende Cerro
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Cordoba, Argentina
- Sanatorio Allende Nueva Córdoba
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Cordoba, Argentina
- Sanatorio Privado del Intenterio SRL
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Corrientes, Argentina
- Hospital Escuela Gral José de San Martín
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Corrientes, Argentina
- Instituto de Cardiologia Juana Francisca Cabral
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Córdoba, Argentina
- Hospital Córdoba
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Córdoba, Argentina
- Hospital Municipal Principe de Asturias
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Córdoba, Argentina
- Hospital Publico Provincial de la Ciudad de Córdoba
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Formosa, Argentina
- Hospital Central de Formosa
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General Roca, Argentina
- Sanatorio Juan XXIII
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González Catán, Argentina
- Hospital Simplemente Evita
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Granadero Baigorria, Argentina
- Hospital Eva Perón
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Haedo, Argentina
- Hospital Profesor Dr Luis Guemes
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Junín, Argentina
- Clínica la pequeña Familia
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La Pampa, Argentina
- Clínica Argentina
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La Plata, Argentina
- Instituto Medico Platense
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La Plata, Argentina
- HIEA y C "San Juan de Dios"
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La Plata, Argentina
- HIGA San Martín de La Plata
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La Plata, Argentina
- HIGA San Roque
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La Plata, Argentina
- Hospital Español
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La Plata, Argentina
- Hospital Italiano de la Plata
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La Plata, Argentina
- Ipensa
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La Plata, Argentina
- Sanatorio Adventista del Plata
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Lomas De Zamora, Argentina
- HIGA Luisa Cravenna de Gandulfo
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Mar Del Plata, Argentina
- Clinica 25 de Mayo
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Mar Del Plata, Argentina
- HIGA Dr Oscar Alende
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Mendoza, Argentina
- Hospital Central
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Mendoza, Argentina
- Clínica Santa María
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Mendoza, Argentina
- Clinica Sociedad Española de Socorros Mutuos de Mendoza
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Mendoza, Argentina
- Hospital del Carmen
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Mendoza, Argentina
- Hospital Luis C Lagomaggiore
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Mendoza, Argentina
- Hospital Santa Isabel de Hungría
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Merlo, Argentina
- Hospital Eva Perón
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Monte Grande, Argentina
- Clinica Monte Grande
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Moreno, Argentina
- HZGA Mariano y Luciano de la Vega
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Morón, Argentina
- Hospital de Morón
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Morón, Argentina
- Hospital Nacional A. Posadas
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Morón, Argentina
- Sanatorio Clínica Modelo de Moron
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Necochea, Argentina
- Hospital Municipal Emilio Ferreyra
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Neuquén, Argentina
- Clinica CMIC
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Neuquén, Argentina
- Clínica Pasteur
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Neuquén, Argentina
- Clínica San Agustín
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Olivos, Argentina
- Clinica Olivos
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Paraná, Argentina
- Hospital Militar Regional de Parana
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Pergamino, Argentina
- HIGA San Jose de Pergamino
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Pilar, Argentina
- Hospital Universitario Austral
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Pinamar, Argentina
- Hospital Municipal de Pinamar
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Posadas, Argentina
- Hospital Escuela de Agudos Dr. Ramón Madariaga
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Posadas, Argentina
- Hospital Público Autogestión SAMIC el Dorado
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Puerto Iguazu, Argentina
- Hospital de Autogestión Samic Iguazú
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Puerto Madryn, Argentina
- Sanatorio de la Ciudad S.R.L
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Quilmes, Argentina
- Sanatorio de la Trinidad Quilmes
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Ramos Mejía, Argentina
- Sanatorio de la Trinidad Ramos Mejía
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Reconquista, Argentina
- Hospital central Reconquista
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Resistencia, Argentina
- Hospital Dr. Julio Perrando
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Rosario, Argentina
- Sanatorio Parque
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Rosario, Argentina
- Hospital Espanol de Rosario
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Rosario, Argentina
- Policlinico PAMI 1
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Rosario, Argentina
- Sanatorio Mapaci
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Salta, Argentina
- Hospital del Sr. del Milagro
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Salta, Argentina
- Hospital Papa Francisco
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Salta, Argentina
- Hospital Publico de Auogestión Dr Arturo Oñativia
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Salta, Argentina
- HPGD San Bernardo
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San Fernando, Argentina
- HIGA Petrona V. de Cordero de San Fernando
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San Fernando Del Valle De Catamarca, Argentina
- Instituto Medico de la Comunidad
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San Isidro, Argentina
- Sanatorio Las Lomas
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San Isidro, Argentina
- Sanatorio de la Trinidad San Isidro
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San Juan, Argentina
- Centro de Cuidados Intensivos
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San Juan, Argentina
- Clinica Santa Clara de la Porvincia de San Juan
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San Juan, Argentina
- Hospital Dr Guillermo Rawson
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San Juan, Argentina
- Hospital Público descentralizado Dr. Marcial Vicente Quiroga.
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San Justo, Argentina
- Hospital Italiano de San Justo
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San Luis, Argentina
- Hospital Madre Catalina
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San Luis, Argentina
- Hospital San Luis
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San Miguel De Tucumán, Argentina
- Hospital Centro de Salud Zenón Santillán
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San Miguel De Tucumán, Argentina
- Hospital de clínica Presidente Doctor Nicolas Avellaneda
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San Salvador De Jujuy, Argentina
- Sanatorio Lavalle
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San Salvador De Jujuy, Argentina
- Sanatorio Nuestra Sra del Rosario
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Santa Fe, Argentina
- Htal Cullen de Santa Fe
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Santa Fe, Argentina
- Sanatorio Español
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Santa Fe, Argentina
- Sanatorio Santa Fé
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Santiago Del Estero, Argentina
- Centro Integral de Salud Banda
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Santiago Del Estero, Argentina
- Hospital regional Dr. Ramon Carrillo
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Tandil, Argentina
- Hospital Ramón Santamarina
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Temperley, Argentina
- Sanatorio Juncal
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Ushuaia, Argentina
- Hospital Regional de Ushuaia
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Venado Tuerto, Argentina
- Hospital Nodal Dr. Alejandro Gutierrez
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Vicente López, Argentina
- Hospital Houssay
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Viedma, Argentina
- Hospital Artemides Zatti
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All adult patients who require mechanical ventilation for at least 12 hours in the argentinians ICU will be enrolled.
Description
Inclusion Criteria:
- ICU patients requiring Mechanical Ventilation at least for 12 hours
- ICU patients who initiate Mechanical Ventilation in the Operation Room or the Emergency Room
- ICU patients who initiate Mechanical Ventilation in other institution.
Exclusion Criteria:
- Patients under 18 years old
- Patients in Pediatric ICU
- Patients in Coronary ICU
- Patients without requirements of Mechanical Ventilation
- Patients who have been discharged from ICU and re-enter during the enrollment period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Survival in the ICU
Time Frame: Up to 28 days after the enrollment
|
"Survival in the ICU" will be measured as YES or NO at day 28 after the enrollment.
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Up to 28 days after the enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Main reason of Invasive Mechanical Ventilation
Time Frame: 1 day
|
|
1 day
|
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Ventilatory Modes and setting
Time Frame: Up to 10 days
|
Volume Control Ventilation, Pressure Control Ventilation, Pressure Support Ventilation, Synchronized Intermittent Mandatory Ventilation, Other (Proportional Assist Ventilation, Neurally Adjusted Ventilation, Airway Pressure Release Ventilation)
|
Up to 10 days
|
|
Tidal Volume
Time Frame: Up to 10 days
|
Set tidal volume in mililiters
|
Up to 10 days
|
|
Weaning and mortality
Time Frame: Up to 28 days
|
Weaning characteristics and outcome of the patient in terms of mortality.
|
Up to 28 days
|
|
Noninvasive ventilation during weaning and mortality
Time Frame: Up to 28 days
|
The use of NIV during weaning and the outcome of the patient in terms of mortality
|
Up to 28 days
|
|
Incidence of delirium
Time Frame: Up to 28 days
|
Delirium measured with the CAM- ICU.
|
Up to 28 days
|
|
Incidence of ICU acquired weakness
Time Frame: Up to 28 days
|
Periphereal muscle weakness measured with MRC defined as a total value of less than 48 points.
|
Up to 28 days
|
|
Incidence of tracheostomy
Time Frame: Up to 28 days
|
Presence of tracheostomy
|
Up to 28 days
|
|
Sedation and analgesia in mechanical ventilation
Time Frame: Up to 28 days
|
Implementation of sedation and analgesia during the period of mechanical ventilation.
|
Up to 28 days
|
|
Peak Pressure
Time Frame: Up to 10 days
|
Monitored Peak Pressure in centimeters of water
|
Up to 10 days
|
|
Plateau Pressure
Time Frame: Up to 10 days
|
Monitored Plateau Pressure in centimeters of water
|
Up to 10 days
|
|
Applied PEEP
Time Frame: Up to 10 days
|
Set PEEP in centimeters of water
|
Up to 10 days
|
|
Total PEEP
Time Frame: Up to 10 days
|
Monitored total PEEP in centimeters of water
|
Up to 10 days
|
|
Driving Pressure
Time Frame: Up to 10 days
|
Monitored Driving Pressure in centimeters of water as the difference between Total PEEP and Plateau Pressure in centimeters of water
|
Up to 10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gustavo Plotnikow, RT, Sanatorio Anchorena
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
- Brochard L, Rauss A, Benito S, Conti G, Mancebo J, Rekik N, Gasparetto A, Lemaire F. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med. 1994 Oct;150(4):896-903. doi: 10.1164/ajrccm.150.4.7921460.
- Esteban A, Alia I, Gordo F, Fernandez R, Solsona JF, Vallverdu I, Macias S, Allegue JM, Blanco J, Carriedo D, Leon M, de la Cal MA, Taboada F, Gonzalez de Velasco J, Palazon E, Carrizosa F, Tomas R, Suarez J, Goldwasser RS. Extubation outcome after spontaneous breathing trials with T-tube or pressure support ventilation. The Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1997 Aug;156(2 Pt 1):459-65. doi: 10.1164/ajrccm.156.2.9610109. Erratum In: Am J Respir Crit Care Med 1997 Dec;156(6):2028.
- Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
- Esteban A, Anzueto A, Frutos F, Alia I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguia C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002 Jan 16;287(3):345-55. doi: 10.1001/jama.287.3.345.
- Esteban A, Frutos F, Tobin MJ, Alia I, Solsona JF, Valverdu I, Fernandez R, de la Cal MA, Benito S, Tomas R, et al. A comparison of four methods of weaning patients from mechanical ventilation. Spanish Lung Failure Collaborative Group. N Engl J Med. 1995 Feb 9;332(6):345-50. doi: 10.1056/NEJM199502093320601.
- Charlson ME, Charlson RE, Peterson JC, Marinopoulos SS, Briggs WM, Hollenberg JP. The Charlson comorbidity index is adapted to predict costs of chronic disease in primary care patients. J Clin Epidemiol. 2008 Dec;61(12):1234-1240. doi: 10.1016/j.jclinepi.2008.01.006. Epub 2008 Jul 10.
- Protti A, Cressoni M, Santini A, Langer T, Mietto C, Febres D, Chierichetti M, Coppola S, Conte G, Gatti S, Leopardi O, Masson S, Lombardi L, Lazzerini M, Rampoldi E, Cadringher P, Gattinoni L. Lung stress and strain during mechanical ventilation: any safe threshold? Am J Respir Crit Care Med. 2011 May 15;183(10):1354-62. doi: 10.1164/rccm.201010-1757OC. Epub 2011 Feb 4. Erratum In: Am J Respir Crit Care Med. 2012 Jan 1;185(1):115.
- Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
- Esteban A, Frutos-Vivar F, Muriel A, Ferguson ND, Penuelas O, Abraira V, Raymondos K, Rios F, Nin N, Apezteguia C, Violi DA, Thille AW, Brochard L, Gonzalez M, Villagomez AJ, Hurtado J, Davies AR, Du B, Maggiore SM, Pelosi P, Soto L, Tomicic V, D'Empaire G, Matamis D, Abroug F, Moreno RP, Soares MA, Arabi Y, Sandi F, Jibaja M, Amin P, Koh Y, Kuiper MA, Bulow HH, Zeggwagh AA, Anzueto A. Evolution of mortality over time in patients receiving mechanical ventilation. Am J Respir Crit Care Med. 2013 Jul 15;188(2):220-30. doi: 10.1164/rccm.201212-2169OC.
- Azevedo LC, Park M, Salluh JI, Rea-Neto A, Souza-Dantas VC, Varaschin P, Oliveira MC, Tierno PF, dal-Pizzol F, Silva UV, Knibel M, Nassar AP Jr, Alves RA, Ferreira JC, Teixeira C, Rezende V, Martinez A, Luciano PM, Schettino G, Soares M; ERICC (Epidemiology of Respiratory Insufficiency in Critical Care) investigators. Clinical outcomes of patients requiring ventilatory support in Brazilian intensive care units: a multicenter, prospective, cohort study. Crit Care. 2013 Apr 4;17(2):R63. doi: 10.1186/cc12594.
- Tomicic V, Espinoza M, Andresen M, Molina J, Calvo M, Ugarte H, Godoy J, Galvez S, Maurelia JC, Delgado I, Esteban A; Grupo Chileno para el Estudio de la Ventilacion Mecanica. [Characteristics and factors associated with mortality in patients receiving mechanical ventilation: first Chilean multicenter study]. Rev Med Chil. 2008 Aug;136(8):959-67. Epub 2008 Oct 7. Spanish.
- Le Gall JR, Lemeshow S, Saulnier F. A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study. JAMA. 1993 Dec 22-29;270(24):2957-63. doi: 10.1001/jama.270.24.2957. Erratum In: JAMA 1994 May 4;271(17):1321.
- Fabregas N, Ewig S, Torres A, El-Ebiary M, Ramirez J, de La Bellacasa JP, Bauer T, Cabello H. Clinical diagnosis of ventilator associated pneumonia revisited: comparative validation using immediate post-mortem lung biopsies. Thorax. 1999 Oct;54(10):867-73. doi: 10.1136/thx.54.10.867.
- Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
- Chanques G, Jaber S, Barbotte E, Violet S, Sebbane M, Perrigault PF, Mann C, Lefrant JY, Eledjam JJ. Impact of systematic evaluation of pain and agitation in an intensive care unit. Crit Care Med. 2006 Jun;34(6):1691-9. doi: 10.1097/01.CCM.0000218416.62457.56.
- Gelinas C, Johnston C. Pain assessment in the critically ill ventilated adult: validation of the Critical-Care Pain Observation Tool and physiologic indicators. Clin J Pain. 2007 Jul-Aug;23(6):497-505. doi: 10.1097/AJP.0b013e31806a23fb.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 9, 2019
Primary Completion (Actual)
November 30, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
September 25, 2019
First Submitted That Met QC Criteria
September 25, 2019
First Posted (Actual)
September 27, 2019
Study Record Updates
Last Update Posted (Actual)
October 22, 2020
Last Update Submitted That Met QC Criteria
October 21, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- EpVAr
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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