Clinical trial NCT04107467: Mechanical Ventilation Epidemiology in Argentina.
Official title: Mechanical Ventilation Epidemiology in Argentina. EpVAr Multicenter Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiration, Artificial
Epidemiology
Lead sponsor: Argentinian Intensive Care Society
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 950
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: How is the epidemiology of mechanically ventilated patients in the intensive care units of Argentina?

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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival in the ICU
timeFrame: Up to 28 days after the enrollment
Secondary outcomes:
measure: Main reason of Invasive Mechanical Ventilation
timeFrame: 1 day
measure: Ventilatory Modes and setting
timeFrame: Up to 10 days
measure: Tidal Volume
timeFrame: Up to 10 days
measure: Weaning and mortality
timeFrame: Up to 28 days
measure: Noninvasive ventilation during weaning and mortality
timeFrame: Up to 28 days
measure: Incidence of delirium
timeFrame: Up to 28 days
measure: Incidence of ICU acquired weakness
timeFrame: Up to 28 days
measure: Incidence of tracheostomy
timeFrame: Up to 28 days
measure: Sedation and analgesia in mechanical ventilation
timeFrame: Up to 28 days
measure: Peak Pressure
timeFrame: Up to 10 days
measure: Plateau Pressure
timeFrame: Up to 10 days
measure: Applied PEEP
timeFrame: Up to 10 days
measure: Total PEEP
timeFrame: Up to 10 days
measure: Driving Pressure
timeFrame: Up to 10 days
Other outcomes:
Locations:
city: Avellaneda
country: Argentina
facility: Hospital Fiorito
city: Avellaneda
country: Argentina
facility: Sanatorio Norte SRL
city: Bahía Blanca
country: Argentina
facility: Hospital Italiano Regional del Sur
city: Bahía Blanca
country: Argentina
facility: Hospital privado Dr Raul Matera
city: Bariloche
country: Argentina
facility: Hospital Area Programa Bariloche "Ramón Carrillo"
city: Buenos Aires
country: Argentina
facility: Cemic H.U. Pombo
city: Buenos Aires
country: Argentina
facility: CEMIC H.U. Saavedra
city: Buenos Aires
country: Argentina
facility: Clinica La Sagrada Familia
city: Buenos Aires
country: Argentina
facility: Clinica y Maternidad Suizo Argentina
city: Buenos Aires
country: Argentina
facility: Clinica Zabala
city: Buenos Aires
country: Argentina
facility: Clínica Adventista Belgrano
city: Buenos Aires
country: Argentina
facility: Clínica Bazterrica
city: Buenos Aires
country: Argentina
facility: Clínica Pasteleros
city: Buenos Aires
country: Argentina
facility: Complejo Medico de la Policia Federal Churruca Visca
city: Buenos Aires
country: Argentina
facility: Cínica de los Virreyes
city: Buenos Aires
country: Argentina
facility: Hospital Alemán
city: Buenos Aires
country: Argentina
facility: Hospital Alvarez
city: Buenos Aires
country: Argentina
facility: Hospital de Clínicas José de San Martín
city: Buenos Aires
country: Argentina
facility: Hospital de Rehabilitación Respiratoria María Ferrer
city: Buenos Aires
country: Argentina
facility: Hospital de Trauma y Emergencia Dr. Federico Abete
city: Buenos Aires
country: Argentina
facility: Hospital Dr D. Velez Sarsfield
city: Buenos Aires
country: Argentina
facility: Hospital Fernandez
city: Buenos Aires
country: Argentina
facility: Hospital Francisco Javier Muñiz
city: Buenos Aires
country: Argentina
facility: Hospital Generall de Agudos Dr Cosme Argerich
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Naval Pedro Mallo
city: Buenos Aires
country: Argentina
facility: Hospital Piñero
city: Buenos Aires
country: Argentina
facility: Hospital Ramos Mejía
city: Buenos Aires
country: Argentina
facility: Hospital Santojanni SRS
city: Buenos Aires
country: Argentina
facility: Hospital Santojanni
city: Buenos AIres
country: Argentina
facility: Hospital Sirio Libanes
city: Buenos Aires
country: Argentina
facility: Hospital Universitario Fundación Favaloro-UTI 1
city: Buenos Aires
country: Argentina
facility: Hospital Universitario Fundación Favaloro-UTI 2
city: Buenos AIres
country: Argentina
facility: Hospital Universitario UAI
city: Buenos Aires
country: Argentina
facility: HZGA Dr alberto Balestrini
city: Buenos Aires
country: Argentina
facility: Instituto Argentino de Diagnostico y Tratamiento
city: Buenos Aires
country: Argentina
facility: Instituto de Trasplante y Alta Complejidad
city: Buenos Aires
country: Argentina
facility: Instituto Lanari
city: Buenos Aires
country: Argentina
facility: Instituto Médico de Alta Complejidad
city: Buenos Aires
country: Argentina
facility: Sanatorio Anchorena
city: Buenos Aires
country: Argentina
facility: Sanatorio Colegiales
city: Buenos Aires
country: Argentina
facility: Sanatorio de la Trinidad Mitre
city: Buenos Aires
country: Argentina
facility: Sanatorio de la Trinidad Palermo
city: Buenos Aires
country: Argentina
facility: Sanatorio de los Arcos
city: Buenos Aires
country: Argentina
facility: Sanatorio Finochietto
city: Buenos Aires
country: Argentina
facility: Sanatorio Mater Dei
city: Buenos Aires
country: Argentina
facility: Sanatorio Otamendi
city: Carmen de Patagones
country: Argentina
facility: Hospital Municipal de Agudos Dr. Pedro Ecay
city: Cañuelas
country: Argentina
facility: Htal de alta complejidad cuenca alta SAMIC
city: Chacabuco
country: Argentina
facility: Hospital Municipal del Carmen de Chacabuco
city: Chivilcoy
country: Argentina
facility: Hospital de Chivilcoy
city: Cipolletti
country: Argentina
facility: Policlinico Modelo Cipolletti
city: Ciudadela
country: Argentina
facility: Hospital Carrillo de Ciudadela
city: Comodoro Rivadavia
country: Argentina
facility: Clinica del Valle
city: Comodoro Rivadavia
country: Argentina
facility: Hospital Regional V Sanguinetti
city: Comodoro Rivadavia
country: Argentina
facility: Hospital Zonal Alvear
city: Concepción Del Uruguay
country: Argentina
facility: Hospital Justo José de Urquiza
city: Cordoba
country: Argentina
facility: Clinica Chutro
city: Cordoba
country: Argentina
facility: Clínica Santa Maria
city: Cordoba
country: Argentina
facility: Clínica Universitaria Reina Fabiola
city: Cordoba
country: Argentina
facility: Hospital Italiano
city: Cordoba
country: Argentina
facility: Hospital Misericordia Nuevo Siglo
city: Cordoba
country: Argentina
facility: Hospital Privado de Cordoba
city: Cordoba
country: Argentina
facility: Hospital San Roque
city: Cordoba
country: Argentina
facility: Sanatorio Allende Cerro
city: Cordoba
country: Argentina
facility: Sanatorio Allende Nueva Córdoba
city: Cordoba
country: Argentina
facility: Sanatorio Privado del Intenterio SRL
city: Corrientes
country: Argentina
facility: Hospital Escuela Gral José de San Martín
city: Corrientes
country: Argentina
facility: Instituto de Cardiologia Juana Francisca Cabral
city: Córdoba
country: Argentina
facility: Hospital Córdoba
city: Córdoba
country: Argentina
facility: Hospital Municipal Principe de Asturias
city: Córdoba
country: Argentina
facility: Hospital Publico Provincial de la Ciudad de Córdoba
city: Formosa
country: Argentina
facility: Hospital Central de Formosa
city: General Roca
country: Argentina
facility: Sanatorio Juan XXIII
city: González Catán
country: Argentina
facility: Hospital Simplemente Evita
city: Granadero Baigorria
country: Argentina
facility: Hospital Eva Peron
city: Haedo
country: Argentina
facility: Hospital Profesor Dr Luis Guemes
city: Junín
country: Argentina
facility: Clínica la pequeña Familia
city: La Pampa
country: Argentina
facility: Clínica Argentina
city: La Plata
country: Argentina
facility: HIEA y C "San Juan de Dios"
city: La Plata
country: Argentina
facility: HIGA San Martín de La Plata
city: La Plata
country: Argentina
facility: HIGA San Roque
city: La Plata
country: Argentina
facility: Hospital español
city: La Plata
country: Argentina
facility: Hospital Italiano de La Plata
city: La Plata
country: Argentina
facility: Instituto Médico Platense
city: La Plata
country: Argentina
facility: Ipensa
city: La Plata
country: Argentina
facility: Sanatorio Adventista del Plata
city: Lomas De Zamora
country: Argentina
facility: HIGA Luisa Cravenna de Gandulfo
city: Mar Del Plata
country: Argentina
facility: Clinica 25 de Mayo
city: Mar Del Plata
country: Argentina
facility: HIGA Dr Oscar Alende
city: Mendoza
country: Argentina
facility: Clinica Santa Maria
city: Mendoza
country: Argentina
facility: Clinica Sociedad Española de Socorros Mutuos de Mendoza
city: Mendoza
country: Argentina
facility: Hospital Central
city: Mendoza
country: Argentina
facility: Hospital del Carmen
city: Mendoza
country: Argentina
facility: Hospital Luis C Lagomaggiore
city: Mendoza
country: Argentina
facility: Hospital Santa Isabel de Hungría
city: Merlo
country: Argentina
facility: Hospital Eva Perón
city: Monte Grande
country: Argentina
facility: Clínica Monte Grande
city: Moreno
country: Argentina
facility: HZGA Mariano y Luciano de la Vega
city: Morón
country: Argentina
facility: Hospital de Morón
city: Morón
country: Argentina
facility: Hospital Nacional A. Posadas
city: Morón
country: Argentina
facility: Sanatorio Clínica Modelo de Moron
city: Necochea
country: Argentina
facility: Hospital Municipal Emilio Ferreyra
city: Neuquén
country: Argentina
facility: Clinica CMIC
city: Neuquén
country: Argentina
facility: Clínica Pasteur
city: Neuquén
country: Argentina
facility: Clínica San Agustín
city: Olivos
country: Argentina
facility: Clinica Olivos
city: Paraná
country: Argentina
facility: Hospital Militar Regional de Parana
city: Pergamino
country: Argentina
facility: HIGA San Jose de Pergamino
city: Pilar
country: Argentina
facility: Hospital Universitario Austral
city: Pinamar
country: Argentina
facility: Hospital Municipal de Pinamar
city: Posadas
country: Argentina
facility: Hospital Escuela de Agudos Dr. Ramon Madariaga
city: Posadas
country: Argentina
facility: Hospital Público Autogestión SAMIC el Dorado
city: Puerto Iguazu
country: Argentina
facility: Hospital de Autogestión Samic Iguazú
city: Puerto Madryn
country: Argentina
facility: Sanatorio de la Ciudad S.R.L
city: Quilmes
country: Argentina
facility: Sanatorio de la Trinidad Quilmes
city: Ramos Mejía
country: Argentina
facility: Sanatorio de la Trinidad Ramos Mejía
city: Reconquista
country: Argentina
facility: Hospital central Reconquista
city: Resistencia
country: Argentina
facility: Hospital Dr. Julio Perrando
city: Rosario
country: Argentina
facility: Hospital Español de Rosario
city: Rosario
country: Argentina
facility: Policlinico PAMI 1
city: Rosario
country: Argentina
facility: Sanatorio Mapaci
city: Rosario
country: Argentina
facility: Sanatorio Parque
city: Salta
country: Argentina
facility: Hospital del Sr. del Milagro
city: Salta
country: Argentina
facility: Hospital Papa Francisco
city: Salta
country: Argentina
facility: Hospital Publico de Auogestión Dr Arturo Oñativia
city: Salta
country: Argentina
facility: HPGD San Bernardo
city: San Fernando Del Valle De Catamarca
country: Argentina
facility: Instituto Medico de la Comunidad
city: San Fernando
country: Argentina
facility: HIGA Petrona V. de Cordero de San Fernando
city: San Isidro
country: Argentina
facility: Sanatorio de la Trinidad San Isidro
city: San Isidro
country: Argentina
facility: Sanatorio Las Lomas
city: San Juan
country: Argentina
facility: Centro de Cuidados Intensivos
city: San Juan
country: Argentina
facility: Clinica Santa Clara de la Porvincia de San Juan
city: San Juan
country: Argentina
facility: Hospital Dr Guillermo Rawson
city: San Juan
country: Argentina
facility: Hospital Público descentralizado Dr. Marcial Vicente Quiroga.
city: San Justo
country: Argentina
facility: Hospital Italiano de San Justo
city: San Luis
country: Argentina
facility: Hospital Madre Catalina
city: San Luis
country: Argentina
facility: Hospital San Luis
city: San Miguel De Tucumán
country: Argentina
facility: Hospital Centro de Salud Zenón Santillán
city: San Miguel De Tucumán
country: Argentina
facility: Hospital de clínica Presidente Doctor Nicolas Avellaneda
city: San Salvador De Jujuy
country: Argentina
facility: Sanatorio Lavalle
city: San Salvador De Jujuy
country: Argentina
facility: Sanatorio Nuestra Sra del Rosario
city: Santa Fe
country: Argentina
facility: Htal Cullen de Santa Fe
city: Santa Fe
country: Argentina
facility: Sanatorio Español
city: Santa Fe
country: Argentina
facility: Sanatorio Santa Fe
city: Santa Fe
country: Argentina
facility: Sanatorio Santa Fé
city: Santiago Del Estero
country: Argentina
facility: Centro Integral de Salud Banda
city: Santiago Del Estero
country: Argentina
facility: Hospital regional Dr. Ramon Carrillo
city: Tandil
country: Argentina
facility: Hospital Ramón Santamarina
city: Temperley
country: Argentina
facility: Sanatorio Juncal
city: Ushuaia
country: Argentina
facility: Hospital Regional de Ushuaia
city: Venado Tuerto
country: Argentina
facility: Hospital Nodal Dr. Alejandro Gutierrez
city: Vicente López
country: Argentina
facility: Hospital Houssay
city: Viedma
country: Argentina
facility: Hospital Artemides Zatti
Study officials:
affiliation: Sanatorio Anchorena
name: Gustavo Plotnikow, RT
role: PRINCIPAL_INVESTIGATOR
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