Third International Study on Mechanical Ventilation (ISMV)

February 1, 2018 updated by: Andres Esteban, Hospital Universitario Getafe

Third Prospective, Observational, International, Multicenter Study on Mechanical Ventilation

The objective of this study is to obtain a better understanding of the spectrum of use of mechanical ventilation in intensive care units:

  1. Main analysis: To know the all-cause mortality rate in mechanically ventilated patients
  2. Secondary analyses:

    • To know the current status of mechanical ventilation in the intensive care unit and determine the number and percentage of patients who are admitted to an intensive care unit and require mechanical ventilation.
    • To compare the results with prior data collected in previous observational studies (1998 and 2004)
    • Non-invasive positive pressure ventilation
    • Weaning
    • Use of adjuvant therapies as steroids or selective digestive decontamination
    • Sedation including prevalence of delirium in mechanically ventilated patients
    • Prediction of the duration of mechanical ventilation
    • Other

Study Overview

Status

Completed

Detailed Description

Mechanical ventilation is commonly used in patients admitted to intensive care units. Clinical studies have investigated some of the aspects associated with its utilization, and have contributed to improve the knowledge and management of patients with acute respiratory failure. In 1998 the invesgtigators conducted the first international study on mechanical ventilation, including 5183 patients who were mechanically ventilated longer than 12 hours (Esteban A. JAMA 2002). Six years later, the investigators carried out the second international study on mechanical ventilation including 4968 patients. These studies allowed us to analyze the evolution of mechanical ventilation and to judge the concordance of practice with results of randomized trials (Esteban A. Am J Respir Crit Care 2008). The main finding of this study was the high degree of concordance between observed changes in mechanical ventilation practice and changes predicted from reports of randomized controlled trials. However, despite apparently beneficial changes in ventilatory practice, the investigators were not able to detect significant differences in clinical outcomes over this time period. Our results serve as an updated benchmark on the usual care and outcomes of mechanically ventilated patients in a 'real-world' setting.

The investigators now propose to conduct a third international study of mechanical ventilation, 6 years after the 2nd study and 12 years after the original. This will again be a prospective, multicenter single-cohort study, which will enroll consecutive patients who have received mechanical ventilation for at least 12 hours during a 1-month period, and will follow each patient for the duration of mechanical ventilation, up to 28 days. With this 3rd study the investigators aim: 1) to determine if the observed changes that the investigators reported previously are maintained over time; 2) to evaluate if the changes implemented have impacted outcomes; 3) to analyze some aspects related to withdrawal of mechanical ventilation; and implementation non-invasive positive pressure ventilation; and 4) to evaluate what differences may occur between geographical areas.

Study Type

Observational

Enrollment (Actual)

8151

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

      • Bahía Blanca, Argentina
        • Hospital Naval Puerto Belgrano
      • Buenos Aires, Argentina
        • Sanatorio Otamendi y Miroli
      • Buenos Aires, Argentina
        • Clínica Bazterrica
      • Buenos Aires, Argentina
        • Hospital Español
      • Buenos Aires, Argentina
        • Sanatorio Anchorena
      • Buenos Aires, Argentina
        • Clínica Santa Isabel
      • Buenos Aires, Argentina
        • Hospital A. Posadas
      • Buenos Aires, Argentina
        • Hospital Churruca-Visca
      • Buenos Aires, Argentina
        • Hospital General de Agudos Bernardino Rivadavia
      • Buenos Aires, Argentina
        • Hospital General de Agudos Dalmacio Vélez Sársfield
      • Buenos Aires, Argentina
        • Hospital General de Agudos Donacion Francisco Santojanni
      • Buenos Aires, Argentina
        • Hospital General de Agudos Juan A. Fernández
      • Buenos Aires, Argentina
        • Hospital General de Agudos P. Piñeiro
      • Buenos Aires, Argentina
        • Hospital Municipal Coronel Suárez
      • Buenos Aires, Argentina
        • Hospital Universitario, Universidad Abierta Interamericana
      • Buenos Aires, Argentina
        • Sanatorio de la Trinidad
      • Buenos Aires, Argentina
        • Sanatorio de los Arcos
      • Buenos Aires, Argentina
        • Sanatorio Dr. Julio Méndez
      • Buenos Aires, Argentina
        • Sanatorio Mater Dei
      • Comodoro Rivadavia, Argentina
        • Hospital Regional de Comodoro Rivadavia
      • Córdoba, Argentina
        • Hospital Tránsito Cáceres de Allende
      • Córdoba, Argentina
        • Sanatorio Allende
      • General Roca, Argentina
        • Hospital Zonal Francisco López Lima
      • Haedo, Argentina
        • Hospital Interzonal General de Agudo Profesor Dr .Luis Guemes
      • La Plata, Argentina
        • Hospital Interzonal de Agudos San Martin
      • Mar del Plata, Argentina
        • Hospital Privado de Comunidad
      • Mendoza, Argentina
        • Hospital Central
      • Mendoza, Argentina
        • Hospital Lagomaggiore
      • Pilar, Argentina
        • Hospital Universitario Austral
      • Rosario, Argentina
        • Hospital Provincial del Centenario
      • Río Gallegos, Argentina
        • Policlínico Atlántico del Sur
      • Río Grande, Argentina
        • Hospital Regional Rio Grande
      • San Isidro, Argentina
        • Sanatorio de la Trinidad
      • San Isidro, Argentina
        • Sanatorio Las Lomas
      • San Luis, Argentina
        • Hospital de San Luis
      • San Salvador de Jujuy, Argentina
        • Hospital Pablo Soria
      • San Salvador de Jujuy, Argentina
        • Sanatorio Nuestra Señora del Rosario
      • Temperley, Argentina
        • Sanatorio Juncal
      • Vicente López, Argentina
        • Clinica Olivos
      • Villa María, Argentina
        • Clínica Privada de Especialidades de Villa María
      • Adelaide, Australia
        • Calvary Wakefield Hospital
      • Adelaide, Australia
        • Flinders Medical Center
      • Ballarat, Australia
        • Ballarat Health Services
      • Bendigo, Australia
        • Bendigo Hospital
      • Brisbane, Australia
        • Mater Health Services
      • Canberra, Australia
        • Canberra Hospital
      • Darwin, Australia
        • Royal Darwin Hospital
      • Geelong, Australia
        • Barwon Health, Geelong Hospital
      • Hobart, Australia
        • Royal Hobart Hospital
      • Liverpool, Australia
        • Liverpool Hospital
      • Melbourne, Australia
        • Alfred Hospital
      • Melbourne, Australia
        • Royal Melbourne Hospital
      • Melbourne, Australia
        • St Vincent's Hospital
      • Melbourne, Australia
        • The Northern Hospital
      • Melbourne, Australia
        • The Western Hospital
      • Sale, Australia
        • Central Gippsland Hospital
      • Sidney, Australia
        • Concord Hospital
      • Sidney, Australia
        • Nepean Hospital
      • Sidney, Australia
        • St George Hospital
      • Sidney, Australia
        • St Vincent's Hospital
      • La Paz, Bolivia
        • Hospital Obrero No.1
      • La Paz, Bolivia
        • Instituto Gastroenterológico
      • Belo Horizonte, Brazil
        • Hospital da Baleia
      • Belo Horizonte, Brazil
        • Hospital da Polícia Militar
      • Belo Horizonte, Brazil
        • Hospital de Pronto Socorro Risoleta Tolentino Neves
      • Belo Horizonte, Brazil
        • Hospital Dia e Maternidade Unimed-BH
      • Belo Horizonte, Brazil
        • Hospital Felício Rocho
      • Belo Horizonte, Brazil
        • Hospital Júlia Kubitschek
      • Belo Horizonte, Brazil
        • Hospital Luxemburgo
      • Belo Horizonte, Brazil
        • Hospital Madre Teresa
      • Belo Horizonte, Brazil
        • Hospital Nossa Senhora Aparecida
      • Belo Horizonte, Brazil
        • Hospital São Francisco-Setimig
      • Belo Horizonte, Brazil
        • Hospital Universitario Sao Jose
      • Belo Horizonte, Brazil
        • Hospital Vera Cruz
      • Belo Horizonte, Brazil
        • Hospital Vila da Serra
      • Contagem, Brazil
        • Hospital Santa Rita
      • Divinópolis, Brazil
        • Hospital São João de Deus
      • Fortaleza, Brazil
        • Hospital de Messejana
      • Fortaleza, Brazil
        • Hospital Universitario Walter Cantidio
      • Juiz de Fora, Brazil
        • Hospital Universitário da Universidade Federal de Juíz de Fora
      • Lavras, Brazil
        • Hospital Vaz Monteiro
      • Ouro Preto, Brazil
        • Santa Casa de Misericórdia de Ouro Preto
      • Ponte Nova, Brazil
        • Hospital Arnaldo Gavazza Filho
      • Sete Lagoas, Brazil
        • Hospital Nossa Senhora Das Gracas
      • Viçosa, Brazil
        • Hospital São João Batista
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Queen Elizabeth II Health Sciences Centre
    • Ontario
      • Brampton, Ontario, Canada
        • William Osler Health Science Centre
      • Hamilton, Ontario, Canada
        • Saint Joseph Hospital
      • Ottawa, Ontario, Canada
        • Ottawa Hospital
      • Toronto, Ontario, Canada
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada
        • Toronto General Hospital
      • Toronto, Ontario, Canada
        • Toronto Western Hospital
      • Toronto, Ontario, Canada
        • Sunnybrook Health Science Centre
      • Toronto, Ontario, Canada
        • Saint Michael´s Hospital
      • Toronto, Ontario, Canada
        • Toronto Hospital Western Division
      • Copiapo, Chile
        • Hospital de Copiapo
      • Coquimbo, Chile
        • Hospital de Coquimbo
      • Santiago, Chile
        • Instituto Nacional del tórax
      • Beijing, China
        • Beijing Tongren Hospital
      • Beijing, China
        • Beijing Hospital
      • Beijing, China
        • Peking Union Medical College Hospital
      • Beijing, China
        • Beijing Chaoyang Hospital
      • Beijing, China
        • Beijing Huaxin Hospital
      • Beijing, China
        • Beijing TCM Hospital
      • Beijing, China
        • Peking University 3rd Hospital
      • Beijing, China
        • PLA 304 hospital
      • Beijing, China
        • PLA General Hospital
      • Beijing, China
        • Pla Navy General Hospital
      • Beijing, China
        • Sino-Japanese Friendship Hospital
      • Changchun, China
        • Jilin University 2nd Hospital
      • Chengdu, China
        • Sichuan Provincial Hospital
      • Chengdu, China
        • West China Hospital
      • Chongqing, China
        • Chongqing Medical University 1st Hospital
      • Chongqing, China
        • Daping Hospital
      • Chuxiong, China
        • Yunnan Chuxiong People's Hospital
      • Dalian, China
        • Dalian Medical University 1st Hospital
      • Guangdong, China
        • Guangdong General Hospital
      • Guangzhou, China
        • Sun Yet-Sen University 6th Hospital
      • Haikou, China
        • Hainan Medical College Hospital
      • Haikou, China
        • Hainan Provincial People's Hospital
      • Haining, China
        • Zhejiang Haining People's Hospital
      • Hangzhou, China
        • Zhejiang Tongde Hospital
      • Hong Kong, China
        • Queen Elizabeth Hospital
      • Hong Kong, China
        • Prince Of Wales Hospital
      • Hong Kong, China
        • North District Hospital
      • Hong Kong, China
        • Pamela Youde Nethersole Eastern Hospital
      • Hong Kong, China
        • Prince Margaret Hospital
      • Kunming, China
        • Kunming City 3rd People's Hospital
      • Kunming, China
        • Kunming Medical College 1st Hospital
      • Nanchang, China
        • Nanchang University 2nd Hospital
      • Nanjing, China
        • Southeast University Zhongda Hospital
      • Nantong, China
        • Nantong 1st People's Hospital
      • Shijiazhuang, China
        • Hebei Medical University 4th Hospital
      • Suzhou, China
        • Suzhou University 1st Hospital
      • Tangshan, China
        • Fengrun District People's Hospital
      • Wuhan, China
        • Wuhan University Zhongnan Hospital
      • Wuxi, China
        • Wuxi Municipal People's Hospital
      • Xi'an, China
        • Xi'an Jiaotong University 1st Hospital
      • Xuzhou, China
        • Xuzhou Central Hospital
      • Yantai, China
        • Yantai Yuhuangding Hospital
      • Barranquilla, Colombia
        • Clinica General del Norte
      • Bogotá, Colombia
        • Clínica Fundadores
      • Bogotá, Colombia
        • Clínica SHAIO
      • Bogotá, Colombia
        • Grupo Cimca Hospital de San José (medical ICU)
      • Bogotá, Colombia
        • Grupo Cimca Hospital de Suba
      • Bogotá, Colombia
        • Grupo Cimca Hospital San José
      • Bogotá, Colombia
        • Hospital Santa Clara
      • Bucaramanga, Colombia
        • Fundación cardiovascular colombiana
      • Cali, Colombia
        • Centro Medico Imbanaco
      • Cali, Colombia
        • Clínica Fundación Valle Lili
      • Cartagena de Indias, Colombia
        • Nuevo Hospital Bocagrande
      • Ibague, Colombia
        • Hospital Federico Lleras Acosta
      • Itagui, Colombia
        • Hospital San Rafael
      • Medellín, Colombia
        • Clinica Universitaria Bolivariana
      • Medellín, Colombia
        • Clínica Cardiovascular
      • Medellín, Colombia
        • Clínica Las Américas
      • Medellín, Colombia
        • Clínica Medellín & Universidad Pontificia Bolivariana
      • Medellín, Colombia
        • CORBIC
      • Medellín, Colombia
        • Hospital General de Medellin
      • Holbaek, Denmark
        • Holbak
      • Koge, Denmark
        • Koge
      • Naestved, Denmark
        • Naestved
      • Nykobing Falster, Denmark
        • Nykobing Falster
      • Roskilde, Denmark
        • Roskilde
      • Slagelse, Denmark
        • Slagelse
      • Cuenca, Ecuador
        • Hospital Jose Carrasco Arteaga
      • Guayaquil, Ecuador
        • Hospital Luis Vernaza
      • Ibarra, Ecuador
        • Hospital San Vicente de Paúl
      • Quito, Ecuador
        • Hospital Carlos Andrade Marin
      • Quito, Ecuador
        • Hospital de la Policia
      • Quito, Ecuador
        • Hospital de los Valles
      • Quito, Ecuador
        • Hospital de SOLCA (ICU medical surgical & ICU medical)
      • Quito, Ecuador
        • Hospital Enrique Garces
      • Quito, Ecuador
        • Hospital Eugenio Espejo
      • Quito, Ecuador
        • Hospital General de las Fuerzas Armadas
      • Quito, Ecuador
        • Hospital Metropolitano
      • Quito, Ecuador
        • Hospital Pablo Arturo Suárez
      • Cairo, Egypt
        • Cairo University Hospitals
      • Armentieres, France
        • Hôpital d'Armentières
      • Châlons en Champagne, France
        • Centre Hospitalier de Châlons en Champagne
      • Creteil, France
        • CHU Henri Mondor
      • Grenoble, France
        • Chu de Grenoble
      • Le Mans, France
        • Centre Hospitalier du Mans
      • Lyon, France
        • Hôpital Edouard Herriot
      • Montauban, France
        • Centre Hospitalier de Montauban
      • Roanne, France
        • Centre Hospitalier de Roanne
      • Rouen, France
        • CHU Charles Nicolle
      • Saint-Malo, France
        • Centre Hospitalier de Saint-Malo
      • d'Angers, France
        • CHU d'Angers
      • Aachen, Germany
        • Katholische Stiftung Marienhospital Aachen
      • Aachen, Germany
        • Universitaetsklinikum Aachen
      • Andernach, Germany
        • St. Nikolaus-Stiftshospital GmbH
      • Bad Salzungen, Germany
        • Klinikum Bad Salzungen GmbH
      • Bad Urach, Germany
        • Ermstalklinik Bad Urach
      • Berlin, Germany
        • Charité Universitaetsklinikum (ICU medical-surgical & ICU other)
      • Berlin, Germany
        • Lungenklinik Heckeshorn
      • Berlin-Kreuzberg, Germany
        • Vivantes Krankenhaus am Urban
      • Bonn, Germany
        • Evangelisches Waldkrankenhaus Bad Godesberg gGmbH
      • Bonn, Germany
        • Universitaetsklinikum Bonn (ICU medical-surgical & ICU surgical)
      • Cottbus, Germany
        • Carl-Thiem-Klinikum Cottbus gGmbH
      • Darmstadt, Germany
        • Evangelisches Krankenhaus Elisabethenstift gGmbH
      • Dresden, Germany
        • Universitaetsklinikum Carl Gustav Carus
      • Freiburg, Germany
        • Evangelisches Diakoniekrankenhaus
      • Gotinga, Germany
        • Universitaetsklinikum der Georg-August-Universitaet
      • Halle, Germany
        • Staedtisches Krankenhaus Martha-Maria Halle-Doelau gGmbH
      • Hamburg, Germany
        • Allgemeines Krankenhaus Harburg
      • Hannover, Germany
        • Medizinische Hochschule Hannover
      • Lueneburg, Germany
        • Staedtisches Klinikum Lueneburg
      • Magdeburg, Germany
        • Universitaetsklinikum
      • Mühlhausen, Germany
        • Hufeland Klinikum GmbH
      • Neubrandenburg, Germany
        • Dietrich-Bonhoeffer Klinikum Neubrandenburg
      • Regensburg, Germany
        • Klinikum der Universitaet Regensburg
      • Sindelfingen, Germany
        • Ermstalklinik Staedtisches Krankenhaus Sindelfingen
      • Ulm, Germany
        • Bundeswehrkrankenhaus Ulm
      • Wittenberg, Germany
        • Universitaetsklinikum der Martin-Luther-Universitaet Halle-Wittenberg
      • Wolfenbuttel, Germany
        • Staedtisches Klinikum Wolfenbuttel
      • Zeitz, Germany
        • Georgius-Agricola-Klinikum Zeitz
      • Thessaloniki, Greece
        • Agios Pavlos General Hospital
      • Thessaloniki, Greece
        • AHEPA Hospital
      • Thessaloniki, Greece
        • Gennimata Hospital
      • Thessaloniki, Greece
        • Papageorgiou Hospital
      • Debrecen, Hungary
        • Kenézy Hospital
      • Szeged, Hungary
        • University of Szeged (Four ICU)
      • Bhubaneswar, India
        • Kalinga Hospital
      • Calcutta, India
        • Calcutta Medical Research Institute
      • Chennai, India
        • Apollo Hospitals
      • Gurgaon, India
        • Artemis Health Institute
      • Indore, India
        • CHL Apollo Hospital
      • Jamshedpur, India
        • Tata Main Hospital
      • Kolkata, India
        • AMRI Hospitals Kolkata
      • Kolkata, India
        • Calcutta medical research institute (CMRI)
      • Manipal City, India
        • Kasturba Medical College
      • Mumbai, India
        • Tata Memorial Hospital
      • Mumbai, India
        • Bombay Hospital Institute of Medical Sciences
      • Mumbai, India
        • Hinduja Hospital
      • Mumbai, India
        • Saifee Hospital
      • Pune, India
        • Ruby Hall Clinic
      • Surat, India
        • Care Hospitals
      • Vadodara, India
        • Spandan Multispeciality Hospital
      • Bari, Italy
        • Ospedale Policlinico, Università Di Bari
      • Bologna, Italy
        • Policlinico Universitario "S. Orsola-Malpighi"
      • Firenze, Italy
        • Ospedale "San Giovanni Di Dio"
      • Firenze, Italy
        • Ospedale "Santa Maria Annunziata"
      • Milano, Italy
        • Fondazione IRCCS "Cà Grande" Ospedale Maggiore Policlinico, Università Di Milano
      • Monza, Italy
        • Ospedale "San Gerardo", Università Di Milano Bicocca
      • Napoli, Italy
        • Ospedale "V. Monaldi"
      • Napoli, Italy
        • Ospedale Policlinico "Federico II", Università Di Napoli
      • Novara, Italy
        • Ospedale Maggiore Della Carità, Università Del Piemonte Orientale "Amedeo Avogadro"
      • Palermo, Italy
        • Ospedale "Arnas Civico, Di Cristina, Benfratelli"
      • Palermo, Italy
        • Policlinico "P. Giaccone", Università Di Palermo
      • Pavia, Italy
        • Fondazione IRCCS Policlinico "S. Matteo", Università Di Pavia (ICU 1 & ICU 2)
      • Roma, Italy
        • Policlinico "Agostino Gemelli", Università Cattolica Del Sacro Cuore
      • Roma, Italy
        • Policlinico "Umberto I", Università La Sapienza
      • Torino, Italy
        • Ospedale "San Giovanni Battista - Molinette", Università Di Torino
      • Tokyo, Japan
        • Tokyo Women's Medical University
      • Ansan, Korea, Republic of
        • Hospital Korea University of Ansan
      • Anyang, Korea, Republic of
        • Hallym University Medical Center
      • Cheongju, Korea, Republic of
        • Hospital Chungbuk National University
      • Chuncheon, Korea, Republic of
        • Hospital Chuncheon Sacred Heart Hospital, Hallym University Medical Center
      • Daegu, Korea, Republic of
        • Hospital Catholic University of Daegu
      • Gyeongju, Korea, Republic of
        • Hospital Dongguk University of Gyeongju
      • Seoul, Korea, Republic of
        • Asan Medical Center, University of Ulsan
      • Seoul, Korea, Republic of
        • Hospital Ewha Womans University Mokdong
      • Seoul, Korea, Republic of
        • Hospital Severance, Yonsei University Health System
      • Seoul, Korea, Republic of
        • Samsung Medical Center, Sungkyunkwan University
      • Wonju, Korea, Republic of
        • Hospital Yonsei University Wonju Christian
      • Yangsan, Korea, Republic of
        • Hospital Pusan National University of Yangsan
      • Aguascalientes, Mexico
        • Centenario Hospital Miguel Hidalgo
      • Ciudad Madero, Mexico
        • Hospital Regional de Pemex
      • Mexico, DF, Mexico
        • Hospital General de Mexico
      • Mexico, DF, Mexico
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
      • Miguel Hidalgo, Mexico
        • Hospital Español de Mexico
      • Mérida, Mexico
        • Hospital Mérida Yucatán
      • México DF, Mexico
        • Hospital Juarez de Mexico
      • México DF, Mexico
        • Hospital Regional 1° de Octubre, ISSSTE
      • México DF, Mexico
        • Hospital Regional de Zona No.1 del IMSS
      • México DF, Mexico
        • Hospital Ángeles de las Lomas
      • México DF, Mexico
        • Instituto Nacional de Cancerologia
      • México DF, Mexico
        • Umae Hospital De Especialidades Dr. Antonio Fraga Mouret
      • México, DF, Mexico
        • Centro Médico ABC
      • Nuevo León, Mexico
        • Hospital Universitario de Nuevo León 'Dr. Eleuterio González'
      • Villahermosa, Mexico
        • Hospital Regional de Alta Especialidad de la Mujer
      • Rabat, Morocco
        • Hôpital des Specialites
      • Rabat, Morocco
        • Hôpital Ibn Sina (Three units)
      • Rabat, Morocco
        • Hopital Militaire d'Instruction Mohamed V
      • Amsterdam, Netherlands
        • Onze Lieve Vrouwe Gasthuis (OLVG)
      • Amsterdam, Netherlands
        • Vrije Universiteit Medisch Centrum (VUMC) (Three units)
      • Den Haag, Netherlands
        • Medisch Centrum Haaglanden
      • Haarlem, Netherlands
        • Kennemer Gasthuis
      • Heerenveen, Netherlands
        • Tjongerschans Ziekenhuis
      • Hoofddorp, Netherlands
        • Spaarneziekenhuis
      • Leeuwarden, Netherlands
        • Medical Center Leeuwarden (MCL)
      • Maastricht, Netherlands
        • Universitair Medisch Centrum Maastricht
      • Auckland, New Zealand
        • CVICU Auckland City Hospital
      • Auckland, New Zealand
        • DCCM Auckland City Hospital
      • Auckland, New Zealand
        • Middlemore
      • Christchurch, New Zealand
        • Christchurch Hospital
      • Hamilton, New Zealand
        • Waikato
      • Tauranga, New Zealand
        • Tauranga Hospital
      • Wellington, New Zealand
        • Wellington Hospital
      • Chiriquí, Panama
        • Hospital Rafael Hernández
      • Lima, Peru
        • Hospital Edgardo Rebagliatti Martins
      • Lima, Peru
        • Hospital Guillermo Almenara Irigoyen
      • Poznan, Poland
        • Karol Marcinkowski University of Medical Sciences
      • Almada, Portugal
        • Hospital Garcia de Orta
      • Amadora, Portugal
        • Hospital da Luz
      • Cascais, Portugal
        • Hospital de Cascais
      • Lisboa, Portugal
        • Centro Hospitalar de Lisboa Central
      • Lisboa, Portugal
        • Centro Hospitalar de Lisboa Norte
      • Lisboa, Portugal
        • Hospital de Santo Antonio dos Capuchos, Centro Hospitalar de Lisboa Central, E.P.E.
      • Porto, Portugal
        • Centro Hospitalar Do Porto - Hospital Geral De Santo António
      • Porto, Portugal
        • Instituto Portugues de Oncologia Francisco Gentil
      • Seide, Portugal
        • Hospital de Sao Sebastiao
      • Vila-Real, Portugal
        • Centro Hospitalar Tras-os-Montes e Alto Douro
      • San Juan, Puerto Rico, 09221
        • VA Caribbean Health Care System
      • Arkhangelsk, Russian Federation
        • City Hospital Number 1 of Arkhangelsk
      • Ekaterinburg, Russian Federation
        • Hospital No.14
      • Moscow, Russian Federation
        • Hospital No.7
      • Moscow, Russian Federation
        • National Institute Of Surgery Named After A.V. Vishnevskij
      • Riyadh, Saudi Arabia
        • King Saud Bin Abdulaziz University for Health Sciences
      • A Coruña, Spain
        • Hospital Juan Canalejo
      • Albacete, Spain
        • Hospital General de Albacete
      • Alcalá de Henares, Spain
        • Hospital Principe de Asturias
      • Alcorcón, Spain
        • Fundación Hospital Universitario de Alcorcón
      • Alicante, Spain
        • Hospital General de Alicante
      • Alicante, Spain
        • Hospital San Juan
      • Almeria, Spain
        • Hospital Torrecardenas
      • Aranjuez, Spain
        • Hospital del Tajo
      • Arganda, Spain
        • Hospital del Sureste
      • Avilés, Spain
        • Hospital San Agustín
      • Badalona, Spain
        • Hospital Germans Trias i Pujol
      • Baracaldo, Spain
        • Hospital de Cruces
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital Clinic-IDIBAPS (ICU medical & ICU respiratory)
      • Barcelona, Spain
        • Hospital de la Santa Creu y Sant Pau
      • Barcelona, Spain
        • Hospital Sagrado Corazón
      • Barcelona, Spain
        • Hospital SCIAS
      • Cartagena, Spain
        • Hospital Santa Maria del Rosell
      • Castellón De La Plana, Spain
        • Hospital de la Plana
      • Castellón De La Plana, Spain
        • Hospital General de Castellon
      • Castellón De La Plana, Spain
        • Hospital Provincial de Castellón
      • Ciudad Real, Spain
        • Complejo Hospitalario de Ciudad Real
      • Coslada, Spain
        • Hospital del Henares
      • Cáceres, Spain
        • Hospital San Pedro de Alcántara
      • Córdoba, Spain
        • Hospital Universitario Reina Sofía
      • Don Benito, Spain
        • Hospital de Don Benito
      • El Ejido, Spain
        • Hospital del Poniente
      • Elche, Spain
        • Hospital General Universitario de Elche
      • Ferrol, Spain
        • Hospital Arquitecto Marcide
      • Fuenlabrada, Spain
        • Hospital De Fuenlabrada
      • Galdakao, Spain
        • Hospital de Galdakao
      • Getafe, Spain
        • Hospital Universitario de Getafe
      • Gijón, Spain
        • Hospital de Cabueñes
      • Girona, Spain
        • Hospital Universitario Doctor Josep Trueta
      • Granada, Spain
        • Hospital Virgen de las Nieves
      • Guadalajara, Spain
        • Hospital General de Guadalajara
      • Huelva, Spain
        • Hospital Juan Ramón Jimenez
      • Jaen, Spain
        • Complejo Hospitalario de Jaen
      • Jérez de la Frontera, Spain
        • Hospital general de Jerez de la Frontera
      • La Palma, Spain
        • Hospital General de La Palma
      • Las Palmas, Spain
        • Hospital Doctor Negrin
      • Las Palmas, Spain
        • Hospital Insular de Gran Canaria
      • León, Spain
        • Complejo Hospitalario de León
      • Lleida, Spain
        • Hospital Arnau de Vilanova
      • Logroño, Spain
        • Hospital de San Pedro
      • Lugo, Spain
        • Complejo Hospitalario Xeral-Calde
      • Madrid, Spain
        • Hospital 12 de Octubre
      • Madrid, Spain
        • Hospital Gregorio Marañón
      • Madrid, Spain
        • Fundacion Jimenez Diaz
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Hospital Quirón
      • Madrid, Spain
        • Hospital Infanta Leonor
      • Madrid, Spain
        • Hospital de La Princesa
      • Madrid, Spain
        • Hospital 12 de Octubre (Trauma ICU)
      • Madrid, Spain
        • Hospital Universitario de La Paz
      • Majadahonda, Spain
        • Hospital Universitario Puerta de Hierro
      • Malaga, Spain
        • Hospital Universitario Virgen de la Victoria
      • Malaga, Spain
        • Hospital Carlos Haya
      • Mataró, Spain
        • Hospital de Mataro
      • Murcia, Spain
        • Hospital Virgen de la Arrixaca
      • Murcia, Spain
        • Hospital J .M. Morales Meseguer
      • Murcia, Spain
        • Hospital Universitario Reina Sofía
      • Móstoles, Spain
        • Hospital De Mostoles
      • Orihuela, Spain
        • Hospital Vega Baja de Orihuela
      • Ourense, Spain
        • Complejo Hospitalario de Ourense
      • Oviedo, Spain
        • Hospital Central de Asturias
      • Palencia, Spain
        • Hospital Río Carrión
      • Palma De Mallorca, Spain
        • Hospital Son Llatzer
      • Palma De Mallorca, Spain
        • Hospital Universitario Son Espasses
      • Pamplona, Spain
        • Complejo Hospitalario de Navarra
      • Parla, Spain
        • Hospital Infanta Cristina
      • Pontevedra, Spain
        • Complejo Hospitalario Montecelo
      • Reus, Spain
        • Hospital Universitario de San Juan
      • Sabadell, Spain
        • Hospital Parc Tauli
      • Sagunto, Spain
        • Hospital de Sagunto
      • Salamanca, Spain
        • Hospital Clinico De Salamanca
      • Salamanca, Spain
        • Complejo Hospitalario de Salamanca
      • San Sebastian, Spain
        • Complejo Hospitalario de Donostia
      • Santiago de Compostela, Spain
        • Complejo Hospitalario de Santiago de Compostela
      • Segovia, Spain
        • Hospital General de Segovia
      • Sevilla, Spain
        • Hospital Virgen Del Rocio
      • Sevilla, Spain
        • Hospital Universitario de Valme
      • Soria, Spain
        • Hospital General de Soria
      • Terrassa, Spain
        • Hospital Mutua De Terrassa
      • Teruel, Spain
        • Hospital Obispo Polanco
      • Toledo, Spain
        • Complejo Hospitalario de Toledo
      • Torrevieja, Spain
        • Hospital de Torrevieja
      • Valdemoro, Spain
        • Hospital Infanta Elena
      • Valencia, Spain
        • Hospital Universitario Dr. Peset
      • Valencia, Spain
        • Hospital Universitario de La Fe
      • Valladolid, Spain
        • Hospital Rio Hortega
      • Valladolid, Spain
        • Hospital Clínico de Valladolid
      • Vigo, Spain
        • Hospital Meixoeiro
      • Vitoria, Spain
        • Hospital Santiago Apostol
      • Xativa, Spain
        • Hospital Lluis Alcanyis
      • Zamora, Spain
        • Hospital de Zamora
      • Zaragoza, Spain
        • Hospital Clinico Lozano Blesa
      • Zaragoza, Spain
        • Hospital Royo Vilanova
      • Tainan City, Taiwan
        • Chi Mei Medical Center
      • Ariana, Tunisia
        • Hospital Abderrahmane Mami
      • Mahdia, Tunisia
        • Hospital Taher Sfar City
      • Monastir, Tunisia
        • Hospital Fattouma Bourguina (ICU medical & ICU surgical)
      • Sfax, Tunisia
        • CHU Habib Bourguiba
      • Sousse, Tunisia
        • Hospital Universitarie Farhat Hached
      • Bursa, Turkey
        • Uludag University Faculty of Medicine
      • Erciyes, Turkey
        • Erciye Üniversity
      • Istanbul, Turkey
        • Anadolu Medical Center Istanbul
      • Izmir, Turkey
        • Atatürk Hospital
      • Kahramanmaras, Turkey
        • Sutcu İmam University
      • Kirikkale, Turkey
        • Kirikkale University
      • Mersin, Turkey
        • Faculty of Medicine Mersin University
      • Van, Turkey
        • Medical Faculty of Yuzuncu Yil University
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University Of Iowa Hospitals And Clinics
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital Detroit
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Omaha VA Medical Center
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center
      • Newark, New Jersey, United States, 07101
        • UMDNJ-New Jersey Medical School
    • New York
      • New York, New York, United States, 10029
        • The Mount Sinai Medical Center
      • New York, New York, United States, 10457
        • Bronx Lebanon Hospital Center
      • New York, New York, United States, 11215
        • New York Methodist Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma City VA Medical Center
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Health Science Center & VA medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University School of Medicine
    • Texas
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch at Galveston
      • San Antonio, Texas, United States, 78229
        • University Hospital San Antonio and South Texas Veterans Health Care System
      • Temple, Texas, United States, 76508
        • Temple Clinic, Scott & White Healthcare
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin
      • Carmelo, Uruguay
        • CAAMOC Carmelo
      • Colonia, Uruguay
        • Orameco
      • Florida, Uruguay
        • Hospital de Florida
      • Las Piedras, Uruguay
        • CRAMI
      • Maldonado, Uruguay
        • Hospital de Maldonado
      • Maldonado, Uruguay
        • Sanatorio Mautone
      • Mercedes, Uruguay
        • Sanatorio CAMS
      • Montevideo, Uruguay
        • Hospital de Clínicas
      • Montevideo, Uruguay
        • CASMU Nº2
      • Montevideo, Uruguay
        • Circulo Católico
      • Montevideo, Uruguay
        • CUDAM
      • Montevideo, Uruguay
        • Hospital Español
      • Montevideo, Uruguay
        • Hospital Evangélico
      • Montevideo, Uruguay
        • Hospital Maciel
      • Montevideo, Uruguay
        • Hospital Pasteur
      • Montevideo, Uruguay
        • Hospital Policial
      • Montevideo, Uruguay
        • Impassa
      • Montevideo, Uruguay
        • Sanatorio Americano
      • Pando, Uruguay
        • CAAMEPA
      • Paysandú, Uruguay
        • COMEPA
      • Paysandú, Uruguay
        • Hospital Escuela del Litoral
      • Punta del Este, Uruguay
        • Sanatorio Cantegril
      • Anzoategui, Venezuela
        • Hospital Centro de Especialidades
      • Caracas, Venezuela
        • Hospital Clinico Universitario
      • Caracas, Venezuela
        • Hospital de Clínicas
      • Caracas, Venezuela
        • Hospital Miguel Pérez Carreño
      • Hanoi, Vietnam
        • Viet Duc Hospital

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

Probability Sample

Study Population

Mechanically ventilated patients

Description

Inclusion Criteria:

  • Patients who are admitted to the intensive care unit and require invasive mechanical ventilation (endotracheal tube or tracheostomy) for more than 12 hours.
  • Patients who are admitted to the intensive care unit and require non-invasive mechanical ventilation (BIPAP or CPAP with nasal or facial mask) for more than 1 hour.

Exclusion Criteria:

  • Patients less than 18 years old

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
mechanically ventilated patients
  1. Patients who are admitted to the participating intensive care units and require invasive mechanical ventilation (endotracheal tube or tracheostomy) for more than 12 hours.
  2. Patients who are admitted to the participating intensive care units and require non-invasive mechanical ventilation (Bilevel positive airway pressure (BIPAP) or continuous positive airway pressure (CPAP) with nasal or facial mask) for more than 1 hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause Mortality
Time Frame: At day 28 after the beginning of mechanical ventilation
Mortality at discharge from intensive care unit
At day 28 after the beginning of mechanical ventilation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rui Moreno, MD, Hospital de Santo António dos Capuchos, Lisboa, Portugal
  • Study Director: Andres Esteban, MD, PhD, Hospital Universitario de Getafe, Spain
  • Principal Investigator: Fernando Frutos-Vivar, MD, Hospital Universitario de Getafe, Spain
  • Principal Investigator: Niall D Ferguson, MD, MsC, University of Toronto, Ontario, Canada
  • Principal Investigator: Antonio Anzueto, MD, University of Texas Health Science Center, San Antonio, Texas, USA
  • Principal Investigator: Marco González, MD, Clinica Medellin & Universidad Pontificia Bolivariana, Colombia
  • Principal Investigator: Arnaud W Thille, MD, AP-HP, Centre Hospitalier Albert Chenevier, Henri Mondor, Créteil, France
  • Principal Investigator: Konstantinos Raymondos, MD, Hannover Medical School
  • Principal Investigator: Salvatore Maggiore, MD, Agostino Gemelli University Hospital, Università Cattolica del Sacro Cuore, Rome, Italy
  • Principal Investigator: Yaseen Arabi, MD, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia
  • Principal Investigator: Fekri Abroug, MD, Fattouma Bourguiba, Monastir, Tunisia
  • Principal Investigator: Javier Hurtado, MD, Hospital de Clínicas, Montevideo, Uruguay
  • Principal Investigator: Fernando Rios, MD, Hospital A.Posadas, Buenos Aires, Argentina
  • Principal Investigator: Luis Soto, MD, Hospital Nacional del Tórax, Santiago, Chile
  • Principal Investigator: Damian Violi, MD, Hospital HIGA, Güemes, Argentina
  • Principal Investigator: Jasmine Board, MD, Alfred Hospital, Melbourne, Australia
  • Principal Investigator: Andrew Davies, MD, Alfred Hospital, Melbourne, Australia
  • Principal Investigator: Fredi Sandi Lora, MD, Hospital Obrero Número 1, La Paz, Bolivia
  • Principal Investigator: Marco Antonio Soares Reis, MD, Hospital Universitário São José, Belo Horizonte, Brazil
  • Principal Investigator: Bin Du, MD, Peking Union Medical College Hospital, Beijing, Popular Republic of China
  • Principal Investigator: Hans-Henrik Bülow, MD, Holbak, Denmark
  • Principal Investigator: Manuel Jibaja, MD, Hospital Militar de Quito, Ecuador
  • Principal Investigator: Dimitros Matamis, MD, Papageorgiou Hospital, Thessaloniki, Greece
  • Principal Investigator: Younsuck Koh, MD, Asan Medical Center, University of Ulsan, Seoul, Korea
  • Principal Investigator: Asisclo Villagómez, MD, Hospital Regional 1° de Octubre, ISSSTE, México DF, Mexico
  • Principal Investigator: Amine Ali Zeggwagh, MD, Hôpital Ibn Sina, Rabat, Morocco
  • Principal Investigator: Michael Kuiper, MD, Medical Center Leeuwarden (MCL), Leeuwarden, The Netherlands
  • Principal Investigator: Edward Nicolayenko, MD, Hospital No.1, Moscow, Russian Federation
  • Principal Investigator: Nicolas Nin, MD, Hospital Universitario de Getafe, Spain
  • Principal Investigator: Nahit Cakar, MD, Istanbul Medical Faculty, Istanbul, Turkey
  • Principal Investigator: Gabriel D'Empaire, MD, Hospital de Clinicas de Caracas, Venezuela

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

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

April 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

March 23, 2010

First Submitted That Met QC Criteria

March 24, 2010

First Posted (Estimate)

March 25, 2010

Study Record Updates

Last Update Posted (Actual)

March 1, 2018

Last Update Submitted That Met QC Criteria

February 1, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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