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Trial record 15 of 647 for:    Russian Federation | Chile

Third International Study on Mechanical Ventilation (ISMV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01093482
Recruitment Status : Completed
First Posted : March 25, 2010
Results First Posted : January 26, 2018
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Andres Esteban, Hospital Universitario Getafe

Brief Summary:

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

Condition or disease
Acute Respiratory Failure

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.


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Study Type : Observational
Actual Enrollment : 8151 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Third Prospective, Observational, International, Multicenter Study on Mechanical Ventilation
Study Start Date : April 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : September 2010

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.



Primary Outcome Measures :
  1. All-cause Mortality [ Time Frame: At day 28 after the beginning of mechanical ventilation ]
    Mortality at discharge from intensive care unit



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Mechanically ventilated patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093482


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Locations
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United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
University of Louisville School of Medicine
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
United States, Michigan
Henry Ford Hospital Detroit
Detroit, Michigan, United States, 48202
United States, Nebraska
Omaha VA Medical Center
Omaha, Nebraska, United States, 68105
United States, New Jersey
Morristown Medical Center
Morristown, New Jersey, United States, 07960
UMDNJ-New Jersey Medical School
Newark, New Jersey, United States, 07101
United States, New York
The Mount Sinai Medical Center
New York, New York, United States, 10029
Bronx Lebanon Hospital Center
New York, New York, United States, 10457
New York Methodist Hospital
New York, New York, United States, 11215
United States, Oklahoma
Oklahoma City VA Medical Center
Oklahoma City, Oklahoma, United States, 73104
Oklahoma University Health Science Center & VA medical Center
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Vanderbilt University School Of Medicine
Nashville, Tennessee, United States, 37232
United States, Texas
University Of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555
University Hospital San Antonio and South Texas Veterans Health Care System
San Antonio, Texas, United States, 78229
Temple Clinic, Scott & White Healthcare
Temple, Texas, United States, 76508
United States, Wisconsin
Medical College Of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Argentina
Hospital Naval Puerto Belgrano
Bahía Blanca, Argentina
Clinica Bazterrica
Buenos Aires, Argentina
Clínica Santa Isabel
Buenos Aires, Argentina
Hospital A. Posadas
Buenos Aires, Argentina
Hospital Churruca-Visca
Buenos Aires, Argentina
Hospital Español
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 donación Francisco Santojanni
Buenos Aires, Argentina
Hospital General de Agudos Juan A. Fernandez
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 Anchorena
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
Buenos Aires, Argentina
Sanatorio Otamendi y Miroli
Buenos Aires, Argentina
Hospital Regional de Comodoro Rivadavia
Comodoro Rivadavia, Argentina
Hospital Tránsito Cáceres de Allende
Córdoba, Argentina
Sanatorio Allende
Córdoba, Argentina
Hospital Zonal Francisco López Lima
General Roca, Argentina
Hospital Interzonal General de Agudo Profesor Dr .Luis Guemes
Haedo, Argentina
Hospital Interzonal de Agudos San Martin
La Plata, Argentina
Hospital Privado de Comunidad
Mar del Plata, Argentina
Hospital Central
Mendoza, Argentina
Hospital Lagomaggiore
Mendoza, Argentina
Hospital Universitario Austral
Pilar, Argentina
Hospital Provincial del Centenario
Rosario, Argentina
Policlínico Atlántico del Sur
Río Gallegos, Argentina
Hospital Regional Rio Grande
Río Grande, Argentina
Sanatorio de la Trinidad
San Isidro, Argentina
Sanatorio Las Lomas
San Isidro, Argentina
Hospital de San Luis
San Luis, Argentina
Hospital Pablo Soria
San Salvador de Jujuy, Argentina
Sanatorio Nuestra Señora del Rosario
San Salvador de Jujuy, Argentina
Sanatorio Juncal
Temperley, Argentina
Clínica Olivos
Vicente López, Argentina
Clínica Privada de Especialidades de Villa María
Villa María, Argentina
Australia
Calvary Wakefield Hospital
Adelaide, Australia
Flinders Medical Center
Adelaide, Australia
Ballarat Health Services
Ballarat, Australia
Bendigo Hospital
Bendigo, Australia
Mater Health Services
Brisbane, Australia
Canberra Hospital
Canberra, Australia
Royal Darwin Hospital
Darwin, Australia
Barwon Health, Geelong Hospital
Geelong, Australia
Royal Hobart Hospital
Hobart, Australia
Liverpool Hospital
Liverpool, Australia
Alfred Hospital
Melbourne, Australia
Royal Melbourne Hospital
Melbourne, Australia
St Vincent's Hospital
Melbourne, Australia
The Northern Hospital
Melbourne, Australia
The Western Hospital
Melbourne, Australia
Central Gippsland Hospital
Sale, Australia
Concord Hospital
Sidney, Australia
Nepean Hospital
Sidney, Australia
St George Hospital
Sidney, Australia
St Vincent's Hospital
Sidney, Australia
Bolivia
Hospital Obrero No.1
La Paz, Bolivia
Instituto Gastroenterológico
La Paz, Bolivia
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
Belo Horizonte, Brazil
Hospital Santa Rita
Contagem, Brazil
Hospital São João de Deus
Divinópolis, Brazil
Hospital de Messejana
Fortaleza, Brazil
Hospital Universitário Walter Cantídio
Fortaleza, Brazil
Hospital Universitário da Universidade Federal de Juiz de Fora
Juiz de Fora, Brazil
Hospital Vaz Monteiro
Lavras, Brazil
Santa Casa de Misericórdia de Ouro Preto
Ouro Preto, Brazil
Hospital Arnaldo Gavazza Filho
Ponte Nova, Brazil
Hospital Nossa Senhora das Graças
Sete Lagoas, Brazil
Hospital São João Batista
Viçosa, Brazil
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Canada, Ontario
William Osler Health Science Centre
Brampton, Ontario, Canada
Saint Joseph Hospital
Hamilton, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Saint Michael´s Hospital
Toronto, Ontario, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Toronto Hospital Western Division
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Chile
Hospital de Copiapo
Copiapo, Chile
Hospital de Coquimbo
Coquimbo, Chile
Instituto Nacional del Tórax
Santiago, Chile
China
Beijing Chaoyang Hospital
Beijing, China
Beijing Hospital
Beijing, China
Beijing Huaxin Hospital
Beijing, China
Beijing TCM Hospital
Beijing, China
Beijing Tongren Hospital
Beijing, China
Peking Union Medical College 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
Beijing, China
Jilin University 2nd Hospital
Changchun, China
Sichuan Provincial Hospital
Chengdu, China
West China Hospital
Chengdu, China
Chongqing Medical University 1st Hospital
Chongqing, China
Daping Hospital
Chongqing, China
Yunnan Chuxiong People's Hospital
Chuxiong, China
Dalian Medical University 1st Hospital
Dalian, China
Guangdong General Hospital
Guangdong, China
Sun Yet-Sen University 6th Hospital
Guangzhou, China
Hainan Medical College Hospital
Haikou, China
Hainan Provincial People's Hospital
Haikou, China
Zhejiang Haining People's Hospital
Haining, China
Zhejiang Tongde Hospital
Hangzhou, China
North District Hospital
Hong Kong, China
Pamela Youde Nethersole Eastern Hospital
Hong Kong, China
Prince Margaret Hospital
Hong Kong, China
Prince Of Wales Hospital
Hong Kong, China
Queen Elizabeth Hospital
Hong Kong, China
Kunming City 3rd People's Hospital
Kunming, China
Kunming Medical College 1st Hospital
Kunming, China
Nanchang University 2nd Hospital
Nanchang, China
Southeast University Zhongda Hospital
Nanjing, China
Nantong 1st People's Hospital
Nantong, China
Hebei Medical University 4th Hospital
Shijiazhuang, China
Suzhou University 1st Hospital
Suzhou, China
Fengrun District People's Hospital
Tangshan, China
Wuhan University Zhongnan Hospital
Wuhan, China
Wuxi Municipal People's Hospital
Wuxi, China
Xi'an Jiaotong University 1st Hospital
Xi'an, China
Xuzhou Central Hospital
Xuzhou, China
Yantai Yuhuangding Hospital
Yantai, China
Colombia
Clínica General del Norte
Barranquilla, 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
Bogotá, Colombia
Fundación cardiovascular colombiana
Bucaramanga, Colombia
Centro Medico Imbanaco
Cali, Colombia
Clínica Fundación Valle Lili
Cali, Colombia
Nuevo Hospital Bocagrande
Cartagena de Indias, Colombia
Hospital Federico Lleras Acosta
Ibague, Colombia
Hospital San Rafael
Itagui, 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 Medellín
Medellín, Colombia
Denmark
Holbak
Holbaek, Denmark
Koge
Koge, Denmark
Naestved
Naestved, Denmark
Nykobing Falster
Nykobing Falster, Denmark
Roskilde
Roskilde, Denmark
Slagelse
Slagelse, Denmark
Ecuador
Hospital José Carrasco Arteaga
Cuenca, Ecuador
Hospital Luis Vernaza
Guayaquil, Ecuador
Hospital San Vicente de Paul
Ibarra, Ecuador
Hospital Carlos Andrade Marín
Quito, Ecuador
Hospital de la Policía
Quito, Ecuador
Hospital de los Valles
Quito, Ecuador
Hospital de SOLCA (ICU medical surgical & ICU medical)
Quito, Ecuador
Hospital Enrique Garcés
Quito, Ecuador
Hospital Eugenio Espejo
Quito, Ecuador
Hospital General de las Fuerzas Armadas
Quito, Ecuador
Hospital Metropolitano
Quito, Ecuador
Hospital Pablo Arturo Suárez
Quito, Ecuador
Egypt
Cairo University Hospitals
Cairo, Egypt
France
Hôpital d'Armentières
Armentieres, France
Centre Hospitalier de Châlons en Champagne
Châlons en Champagne, France
CHU Henri Mondor
Creteil, France
CHU d'Angers
d'Angers, France
CHU De Grenoble
Grenoble, France
Centre Hospitalier Du Mans
Le Mans, France
Hôpital Édouard Herriot
Lyon, France
Centre Hospitalier De Montauban
Montauban, France
Centre Hospitalier De Roanne
Roanne, France
CHU Charles Nicolle
Rouen, France
Centre Hospitalier De Saint-Malo
Saint-Malo, France
Germany
Katholische Stiftung Marienhospital Aachen
Aachen, Germany
Universitaetsklinikum Aachen
Aachen, Germany
St. Nikolaus-Stiftshospital GmbH
Andernach, Germany
Klinikum Bad Salzungen GmbH
Bad Salzungen, Germany
Ermstalklinik Bad Urach
Bad Urach, Germany
Vivantes Krankenhaus am Urban
Berlin-Kreuzberg, Germany
Charité Universitaetsklinikum (ICU medical-surgical & ICU other)
Berlin, Germany
Lungenklinik Heckeshorn
Berlin, Germany
Evangelisches Waldkrankenhaus Bad Godesberg gGmbH
Bonn, Germany
Universitaetsklinikum Bonn (ICU medical-surgical & ICU surgical)
Bonn, Germany
Carl-Thiem-Klinikum Cottbus gGmbH
Cottbus, Germany
Evangelisches Krankenhaus Elisabethenstift gGmbH
Darmstadt, Germany
Universitaetsklinikum Carl Gustav Carus
Dresden, Germany
Evangelisches Diakoniekrankenhaus
Freiburg, Germany
Universitaetsklinikum der Georg-August-Universitaet
Gotinga, Germany
Staedtisches Krankenhaus Martha-Maria Halle-Doelau gGmbH
Halle, Germany
Allgemeines Krankenhaus Harburg
Hamburg, Germany
Medizinische Hochschule Hannover
Hannover, Germany
Staedtisches Klinikum Lueneburg
Lueneburg, Germany
Universitaetsklinikum
Magdeburg, Germany
Hufeland Klinikum GmbH
Mühlhausen, Germany
Dietrich-Bonhoeffer Klinikum Neubrandenburg
Neubrandenburg, Germany
Klinikum der Universitaet Regensburg
Regensburg, Germany
Ermstalklinik Staedtisches Krankenhaus Sindelfingen
Sindelfingen, Germany
Bundeswehrkrankenhaus Ulm
Ulm, Germany
Universitaetsklinikum der Martin-Luther-Universitaet Halle-Wittenberg
Wittenberg, Germany
Staedtisches Klinikum Wolfenbuttel
Wolfenbuttel, Germany
Georgius-Agricola-Klinikum Zeitz
Zeitz, Germany
Greece
Agios Pavlos General Hospital
Thessaloniki, Greece
Ahepa Hospital
Thessaloniki, Greece
Gennimata Hospital
Thessaloniki, Greece
Papageorgiou Hospital
Thessaloniki, Greece
Hungary
Kenezy Hospital
Debrecen, Hungary
University of Szeged (Four ICU)
Szeged, Hungary
India
Kalinga Hospital
Bhubaneswar, India
Calcutta Medical Research Institute
Calcutta, India
Apollo Hospitals
Chennai, India
Artemis Health Institute
Gurgaon, India
CHL Apollo Hospital
Indore, India
Tata Main Hospital
Jamshedpur, India
AMRI Hospitals Kolkata
Kolkata, India
Calcutta medical research institute (CMRI)
Kolkata, India
Kasturba Medical College
Manipal City, India
Bombay Hospital Institute of Medical Sciences
Mumbai, India
Hinduja Hospital
Mumbai, India
Saifee Hospital
Mumbai, India
Tata Memorial Hospital
Mumbai, India
Ruby Hall Clinic
Pune, India
CARE Hospitals
Surat, India
Spandan Multispeciality Hospital
Vadodara, India
Italy
Ospedale Policlinico, Università Di Bari
Bari, Italy
Policlinico Universitario "S. Orsola-Malpighi"
Bologna, Italy
Ospedale "San Giovanni Di Dio"
Firenze, Italy
Ospedale "Santa Maria Annunziata"
Firenze, Italy
Fondazione IRCCS "Cà Grande" Ospedale Maggiore Policlinico, Università Di Milano
Milano, Italy
Ospedale "San Gerardo", Università Di Milano Bicocca
Monza, Italy
Ospedale "V. Monaldi"
Napoli, Italy
Ospedale Policlinico "Federico II", Università Di Napoli
Napoli, Italy
Ospedale Maggiore Della Carità, Università Del Piemonte Orientale "Amedeo Avogadro"
Novara, Italy
Ospedale "Arnas Civico, Di Cristina, Benfratelli"
Palermo, Italy
Policlinico "P. Giaccone", Università Di Palermo
Palermo, Italy
Fondazione IRCCS Policlinico "S. Matteo", Università Di Pavia (ICU 1 & ICU 2)
Pavia, Italy
Policlinico "Agostino Gemelli", Università Cattolica Del Sacro Cuore
Roma, Italy
Policlinico "Umberto I", Università La Sapienza
Roma, Italy
Ospedale "San Giovanni Battista - Molinette", Università Di Torino
Torino, Italy
Japan
Tokyo Women's Medical University
Tokyo, Japan
Korea, Republic of
Hospital Korea University of Ansan
Ansan, Korea, Republic of
Hallym University Medical Center
Anyang, Korea, Republic of
Hospital Chungbuk National University
Cheongju, Korea, Republic of
Hospital Chuncheon Sacred Heart Hospital, Hallym University Medical Center
Chuncheon, Korea, Republic of
Hospital Catholic University of Daegu
Daegu, Korea, Republic of
Hospital Dongguk University of Gyeongju
Gyeongju, 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
Seoul, Korea, Republic of
Hospital Yonsei University Wonju Christian
Wonju, Korea, Republic of
Hospital Pusan National University of Yangsan
Yangsan, Korea, Republic of
Mexico
Centenario Hospital Miguel Hidalgo
Aguascalientes, Mexico
Hospital Regional de Pemex
Ciudad Madero, Mexico
Hospital General de México
Mexico, DF, Mexico
Instituto Nacional De Ciencias Médicas y Nutrición Salvador Zubirán
Mexico, DF, Mexico
Hospital Español de México
Miguel Hidalgo, Mexico
Hospital Mérida Yucatán
Mérida, Mexico
Hospital Juárez de México
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 Cancerología
México DF, Mexico
Umae Hospital De Especialidades Dr. Antonio Fraga Mouret
México DF, Mexico
Centro Médico ABC
México, DF, Mexico
Hospital Universitario de Nuevo León 'Dr. Eleuterio González'
Nuevo León, Mexico
Hospital Regional de Alta Especialidad de la Mujer
Villahermosa, Mexico
Morocco
Hôpital des Specialites
Rabat, Morocco
Hôpital Ibn Sina (Three units)
Rabat, Morocco
Hôpital Militaire D'Instruction Mohamed V
Rabat, Morocco
Netherlands
Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam, Netherlands
Vrije Universiteit Medisch Centrum (VUMC) (Three units)
Amsterdam, Netherlands
Medisch Centrum Haaglanden
Den Haag, Netherlands
Kennemer Gasthuis
Haarlem, Netherlands
Tjongerschans Ziekenhuis
Heerenveen, Netherlands
Spaarneziekenhuis
Hoofddorp, Netherlands
Medical Center Leeuwarden (MCL)
Leeuwarden, Netherlands
Universitair Medisch Centrum Maastricht
Maastricht, Netherlands
New Zealand
CVICU Auckland City Hospital
Auckland, New Zealand
DCCM Auckland City Hospital
Auckland, New Zealand
Middlemore
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Waikato
Hamilton, New Zealand
Tauranga Hospital
Tauranga, New Zealand
Wellington Hospital
Wellington, New Zealand
Panama
Hospital Rafael Hernández
Chiriquí, Panama
Peru
Hospital Edgardo Rebagliatti Martins
Lima, Peru
Hospital Guillermo Almenara Irigoyen
Lima, Peru
Poland
Karol Marcinkowski University Of Medical Sciences
Poznan, Poland
Portugal
Hospital Garcia de Orta
Almada, Portugal
Hospital da Luz
Amadora, Portugal
Hospital de Cascais
Cascais, 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.
Lisboa, Portugal
Centro Hospitalar Do Porto - Hospital Geral De Santo António
Porto, Portugal
Instituto Português de Oncología Francisco Gentil
Porto, Portugal
Hospital De São Sebastião
Seide, Portugal
Centro Hospitalar Trás-Os-Montes E Alto Douro
Vila-Real, Portugal
Puerto Rico
VA Caribbean Health Care System
San Juan, Puerto Rico, 09221
Russian Federation
City Hospital Number 1 of Arkhangelsk
Arkhangelsk, Russian Federation
Hospital No.14
Ekaterinburg, Russian Federation
Hospital No.7
Moscow, Russian Federation
National Institute Of Surgery Named After A.V. Vishnevskij
Moscow, Russian Federation
Saudi Arabia
King Saud Bin Abdulaziz University for Health Sciences
Riyadh, Saudi Arabia
Spain
Hospital Juan Canalejo
A Coruña, Spain
Hospital General de Albacete
Albacete, Spain
Hospital Príncipe de Asturias
Alcalá de Henares, Spain
Fundación Hospital Universitario de Alcorcón
Alcorcón, Spain
Hospital General de Alicante
Alicante, Spain
Hospital San Juan
Alicante, Spain
Hospital Torrecárdenas
Almeria, Spain
Hospital del Tajo
Aranjuez, Spain
Hospital del Sureste
Arganda, Spain
Hospital San Agustín
Avilés, Spain
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital de Cruces
Baracaldo, Spain
Hospital Clinic-IDIBAPS (ICU medical & ICU respiratory)
Barcelona, Spain
Hospital de la Santa Creu y Sant Pau
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Sagrado Corazón
Barcelona, Spain
Hospital SCIAS
Barcelona, Spain
Hospital Santa María del Rosell
Cartagena, Spain
Hospital de la Plana
Castellón De La Plana, Spain
Hospital General de Castellón
Castellón De La Plana, Spain
Hospital Provincial de Castellón
Castellón De La Plana, Spain
Complejo Hospitalario de Ciudad Real
Ciudad Real, Spain
Hospital del Henares
Coslada, Spain
Hospital San Pedro de Alcántara
Cáceres, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
Hospital de Don Benito
Don Benito, Spain
Hospital del Poniente
El Ejido, Spain
Hospital General Universitario de Elche
Elche, Spain
Hospital Arquitecto Marcide
Ferrol, Spain
Hospital de Fuenlabrada
Fuenlabrada, Spain
Hospital de Galdakao
Galdakao, Spain
Hospital Universitario de Getafe
Getafe, Spain
Hospital de Cabueñes
Gijón, Spain
Hospital Universitario Doctor Josep Trueta
Girona, Spain
Hospital Virgen de las Nieves
Granada, Spain
Hospital General de Guadalajara
Guadalajara, Spain
Hospital Juan Ramón Jimenez
Huelva, Spain
Complejo Hospitalario de Jaen
Jaen, Spain
Hospital General de Jerez de la Frontera
Jérez de la Frontera, Spain
Hospital General de La Palma
La Palma, Spain
Hospital Doctor Negrín
Las Palmas, Spain
Hospital Insular de Gran Canaria
Las Palmas, Spain
Complejo Hospitalario de León
León, Spain
Hospital Arnau de Vilanova
Lleida, Spain
Hospital de San Pedro
Logroño, Spain
Complejo Hospitalario Xeral-Calde
Lugo, Spain
Fundación Jiménez Díaz
Madrid, Spain
Hospital 12 de Octubre (Trauma ICU)
Madrid, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital de la Princesa
Madrid, Spain
Hospital Gregorio Marañón
Madrid, Spain
Hospital Infanta Leonor
Madrid, Spain
Hospital Quirón
Madrid, Spain
Hospital Universitario de la Paz
Madrid, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Spain
Hospital Carlos Haya
Malaga, Spain
Hospital Universitario Virgen de la Victoria
Malaga, Spain
Hospital de Mataró
Mataró, Spain
Hospital J .M. Morales Meseguer
Murcia, Spain
Hospital Universitario Reina Sofia
Murcia, Spain
Hospital Virgen de la Arrixaca
Murcia, Spain
Hospital de Móstoles
Móstoles, Spain
Hospital Vega Baja de Orihuela
Orihuela, Spain
Complejo Hospitalario de Ourense
Ourense, Spain
Hospital Central de Asturias
Oviedo, Spain
Hospital Rio Carrión
Palencia, Spain
Hospital Son Llatzer
Palma De Mallorca, Spain
Hospital Universitario Son Espasses
Palma De Mallorca, Spain
Complejo Hospitalario de Navarra
Pamplona, Spain
Hospital Infanta Cristina
Parla, Spain
Complejo Hospitalario Montecelo
Pontevedra, Spain
Hospital Universitario de San Juan
Reus, Spain
Hospital Parc Taulí
Sabadell, Spain
Hospital de Sagunto
Sagunto, Spain
Complejo Hospitalario de Salamanca
Salamanca, Spain
Hospital Clínico de Salamanca
Salamanca, Spain
Complejo Hospitalario de Donostia
San Sebastian, Spain
Complejo Hospitalario de Santiago de Compostela
Santiago de Compostela, Spain
Hospital General de Segovia
Segovia, Spain
Hospital Universitario de Valme
Sevilla, Spain
Hospital Virgen del Rocío
Sevilla, Spain
Hospital General de Soria
Soria, Spain
Hospital Mutua de Terrassa
Terrassa, Spain
Hospital Obispo Polanco
Teruel, Spain
Complejo Hospitalario de Toledo
Toledo, Spain
Hospital de Torrevieja
Torrevieja, Spain
Hospital Infanta Elena
Valdemoro, Spain
Hospital Universitario de la Fe
Valencia, Spain
Hospital Universitario Dr. Peset
Valencia, Spain
Hospital Clínico de Valladolid
Valladolid, Spain
Hospital Rio Hortega
Valladolid, Spain
Hospital Meixoeiro
Vigo, Spain
Hospital Santiago Apóstol
Vitoria, Spain
Hospital Lluis Alcanyis
Xativa, Spain
Hospital de Zamora
Zamora, Spain
Hospital Clínico Lozano Blesa
Zaragoza, Spain
Hospital Royo Vilanova
Zaragoza, Spain
Taiwan
Chi Mei Medical Center
Tainan City, Taiwan
Tunisia
Hospital Abderrahmane Mami
Ariana, Tunisia
Hospital Taher Sfar City
Mahdia, Tunisia
Hospital Fattouma Bourguina (ICU medical & ICU surgical)
Monastir, Tunisia
CHU Habib Bourguiba
Sfax, Tunisia
Hospital Universitarie Farhat Hached
Sousse, Tunisia
Turkey
Uludag University Faculty of Medicine
Bursa, Turkey
Erciye Üniversity
Erciyes, Turkey
Anadolu Medical Center Istanbul
Istanbul, Turkey
Atatürk Hospital
Izmir, Turkey
Sutcu İmam University
Kahramanmaras, Turkey
Kirikkale University
Kirikkale, Turkey
Faculty of Medicine Mersin University
Mersin, Turkey
Medical Faculty of Yuzuncu Yil University
Van, Turkey
Uruguay
CAAMOC Carmelo
Carmelo, Uruguay
Orameco
Colonia, Uruguay
Hospital de Florida
Florida, Uruguay
CRAMI
Las Piedras, Uruguay
Hospital de Maldonado
Maldonado, Uruguay
Sanatorio Mautone
Maldonado, Uruguay
Sanatorio CAMS
Mercedes, Uruguay
CASMU Nº2
Montevideo, Uruguay
Circulo Católico
Montevideo, Uruguay
CUDAM
Montevideo, Uruguay
Hospital de Clínicas
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
Montevideo, Uruguay
CAAMEPA
Pando, Uruguay
COMEPA
Paysandú, Uruguay
Hospital Escuela del Litoral
Paysandú, Uruguay
Sanatorio Cantegril
Punta del Este, Uruguay
Venezuela
Hospital Centro de Especialidades
Anzoategui, Venezuela
Hospital Clínico Universitario
Caracas, Venezuela
Hospital de Clínicas
Caracas, Venezuela
Hospital Miguel Pérez Carreño
Caracas, Venezuela
Vietnam
Viet Duc Hospital
Hanoi, Vietnam
Sponsors and Collaborators
Hospital Universitario Getafe
Investigators
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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: Rui Moreno, MD Hospital de Santo António dos Capuchos, Lisboa, Portugal
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andres Esteban, MD, Hospital Universitario Getafe
ClinicalTrials.gov Identifier: NCT01093482     History of Changes
Other Study ID Numbers: ISMV-2010
First Posted: March 25, 2010    Key Record Dates
Results First Posted: January 26, 2018
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andres Esteban, Hospital Universitario Getafe:
mechanical ventilation
epidemiology
outcomes
mortality
weaning
sedation
non-invasive positive pressure ventilation
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases