Acute Respiratory FailureISMVNCT01093482
Third International Study on Mechanical Ventilation
An observational study of Acute Respiratory Failure, run by Hospital Universitario Getafe at 477 sites in 38 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- How many people
- 8,151 participants
- Where
- 477 sitesin 38 countries
- Study dates
- Apr 2010to Sep 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mechanically ventilated patients
Who may be able to join
- 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.
Who cannot join
- Patients less than 18 years old
Trial locations and contacts
477 sites in 38 countries.
477 sites in 38 countries
Spain98 sites
Hospital Juan Canalejo
A Coruña
Hospital General de Albacete
Albacete
Hospital Príncipe de Asturias
Alcalá de Henares
Fundación Hospital Universitario de Alcorcón
Alcorcón
Hospital General de Alicante
Alicante
Hospital San Juan
Alicante
Hospital Torrecárdenas
Almería
Hospital del Tajo
Aranjuez
Hospital del Sureste
Arganda
Hospital San Agustín
Avilés
Hospital Germans Trias i Pujol
Badalona
Hospital de Cruces
Barakaldo
Hospital Clinic-IDIBAPS (ICU medical & ICU respiratory)
Barcelona
Hospital de la Santa Creu y Sant Pau
Barcelona
Hospital del Mar
Barcelona
Hospital Sagrado Corazón
Barcelona
Hospital SCIAS
Barcelona
Hospital San Pedro de Alcántara
Cáceres
Hospital Santa María del Rosell
Cartagena
Hospital de la Plana
Castellon
Hospital General de Castellón
Castellon
Hospital Provincial de Castellón
Castellon
Complejo Hospitalario de Ciudad Real
Ciudad Real
Hospital Universitario Reina Sofia
Córdoba
Hospital del Henares
Coslada
Hospital de Don Benito
Don Benito
Complejo Hospitalario de Donostia
Donostia / San Sebastian
Hospital del Poniente
El Ejido
Hospital General Universitario de Elche
Elche
Hospital Arquitecto Marcide
Ferrol
Hospital de Fuenlabrada
Fuenlabrada
Hospital de Galdakao
Galdakao
Hospital Universitario de Getafe
Getafe
Hospital de Cabueñes
Gijón
Hospital Universitario Doctor Josep Trueta
Girona
Hospital Virgen de las Nieves
Granada
Hospital General de Guadalajara
Guadalajara
Hospital Juan Ramón Jimenez
Huelva
Complejo Hospitalario de Jaen
Jaén
Hospital General de Jerez de la Frontera
Jérez de La Frontera
Hospital General de La Palma
la palma
Hospital Doctor Negrín
Las Palmas
Hospital Insular de Gran Canaria
Las Palmas
Complejo Hospitalario de León
León
Hospital Arnau de Vilanova
Lleida
Hospital de San Pedro
Logroño
Complejo Hospitalario Xeral-Calde
Lugo
Fundación Jiménez Díaz
Madrid
Hospital 12 de Octubre (Trauma ICU)
Madrid
Hospital 12 de Octubre
Madrid
Hospital Clínico San Carlos
Madrid
Hospital de la Princesa
Madrid
Hospital Gregorio Marañón
Madrid
Hospital Infanta Leonor
Madrid
Hospital Quirón
Madrid
Hospital Universitario de la Paz
Madrid
Hospital Universitario Puerta de Hierro
Majadahonda
Hospital Carlos Haya
Málaga
Hospital Universitario Virgen de la Victoria
Málaga
Hospital de Mataró
Mataró
Hospital de Móstoles
Móstoles
Hospital J .M. Morales Meseguer
Murcia
Hospital Universitario Reina Sofia
Murcia
Hospital Virgen de la Arrixaca
Murcia
Hospital Vega Baja de Orihuela
Orihuela
Complejo Hospitalario de Ourense
Ourense
Hospital Central de Asturias
Oviedo
Hospital Rio Carrión
Palencia
Hospital Son Llatzer
Palma de Mallorca
Hospital Universitario Son Espasses
Palma de Mallorca
Complejo Hospitalario de Navarra
Pamplona
Hospital Infanta Cristina
Parla
Complejo Hospitalario Montecelo
Pontevedra
Hospital Universitario de San Juan
Reus
Hospital Parc Taulí
Sabadell
Hospital de Sagunto
Sagunto
Complejo Hospitalario de Salamanca
Salamanca
Hospital Clínico de Salamanca
Salamanca
Complejo Hospitalario de Santiago de Compostela
Santiago de Compostela
Hospital General de Segovia
Segovia
Hospital Universitario de Valme
Seville
Hospital Virgen del Rocío
Seville
Hospital General de Soria
Soria
Hospital Mutua de Terrassa
Terrassa
Hospital Obispo Polanco
Teruel
Complejo Hospitalario de Toledo
Toledo
Hospital de Torrevieja
Torrevieja
Hospital Infanta Elena
Valdemoro
Hospital Universitario de la Fe
Valencia
Hospital Universitario Dr. Peset
Valencia
Hospital Clínico de Valladolid
Valladolid
Hospital Rio Hortega
Valladolid
Hospital Meixoeiro
Vigo
Hospital Santiago Apóstol
Vitoria-Gasteiz
Hospital Lluis Alcanyis
Xàtiva
Hospital de Zamora
Zamora
Hospital Clínico Lozano Blesa
Zaragoza
Hospital Royo Vilanova
Zaragoza
China42 sites
Beijing Chaoyang Hospital
Beijing
Beijing Hospital
Beijing
Beijing Huaxin Hospital
Beijing
Beijing TCM Hospital
Beijing
Beijing Tongren Hospital
Beijing
Peking Union Medical College Hospital
Beijing
Peking University 3rd Hospital
Beijing
PLA 304 Hospital
Beijing
PLA General Hospital
Beijing
PLA Navy General Hospital
Beijing
Sino-Japanese Friendship Hospital
Beijing
Jilin University 2nd Hospital
Changchun
Sichuan Provincial Hospital
Chengdu
West China Hospital
Chengdu
Chongqing Medical University 1st Hospital
Chongqing
Daping Hospital
Chongqing
Yunnan Chuxiong People's Hospital
Chuxiong
Dalian Medical University 1st Hospital
Dalian
Guangdong General Hospital
Guangdong
Sun Yet-Sen University 6th Hospital
Guangzhou
Hainan Medical College Hospital
Haikou
Hainan Provincial People's Hospital
Haikou
Zhejiang Haining People's Hospital
Haining
Zhejiang Tongde Hospital
Hangzhou
North District Hospital
Hong Kong
Pamela Youde Nethersole Eastern Hospital
Hong Kong
Prince Margaret Hospital
Hong Kong
Prince Of Wales Hospital
Hong Kong
Queen Elizabeth Hospital
Hong Kong
Kunming City 3rd People's Hospital
Kunming
Kunming Medical College 1st Hospital
Kunming
Nanchang University 2nd Hospital
Nanchang
Southeast University Zhongda Hospital
Nanjing
Nantong 1st People's Hospital
Nantong
Hebei Medical University 4th Hospital
Shijiazhuang
Suzhou University 1st Hospital
Suzhou
Fengrun District People's Hospital
Tangshan
Wuhan University Zhongnan Hospital
Wuhan
Wuxi Municipal People's Hospital
Wuxi
Xi'an Jiaotong University 1st Hospital
Xi'an
Xuzhou Central Hospital
Xuzhou
Yantai Yuhuangding Hospital
Yantai
Argentina40 sites
Hospital Naval Puerto Belgrano
Bahía Blanca
Clinica Bazterrica
Buenos Aires
Clínica Santa Isabel
Buenos Aires
Hospital A. Posadas
Buenos Aires
Hospital Churruca-Visca
Buenos Aires
Hospital Español
Buenos Aires
Hospital General de Agudos Bernardino Rivadavia
Buenos Aires
Hospital General de Agudos Dalmacio Vélez Sársfield
Buenos Aires
Hospital General de Agudos donación Francisco Santojanni
Buenos Aires
Hospital General de Agudos Juan A. Fernandez
Buenos Aires
Hospital General de Agudos P. Piñeiro
Buenos Aires
Hospital Municipal Coronel Suárez
Buenos Aires
Hospital Universitario, Universidad Abierta Interamericana
Buenos Aires
Sanatorio Anchorena
Buenos Aires
Sanatorio de la Trinidad
Buenos Aires
Sanatorio de los Arcos
Buenos Aires
Sanatorio Dr. Julio Méndez
Buenos Aires
Sanatorio Mater Dei
Buenos Aires
Sanatorio Otamendi y Miroli
Buenos Aires
Hospital Regional de Comodoro Rivadavia
Comodoro Rivadavia
Hospital Tránsito Cáceres de Allende
Córdoba
Sanatorio Allende
Córdoba
Hospital Zonal Francisco López Lima
General Roca
Hospital Interzonal General de Agudo Profesor Dr .Luis Guemes
Haedo
Hospital Interzonal de Agudos San Martin
La Plata
Hospital Privado de Comunidad
Mar del Plata
Hospital Central
Mendoza
Hospital Lagomaggiore
Mendoza
Hospital Universitario Austral
Pilar
Policlínico Atlántico del Sur
Río Gallegos
Hospital Regional Rio Grande
Rio Grande
Hospital Provincial del Centenario
Rosario
Sanatorio de la Trinidad
San Isidro
Sanatorio Las Lomas
San Isidro
Hospital de San Luis
San Luis
Hospital Pablo Soria
San Salvador de Jujuy
Sanatorio Nuestra Señora del Rosario
San Salvador de Jujuy
Sanatorio Juncal
Temperley
Clínica Olivos
Vicente López
Clínica Privada de Especialidades de Villa María
Villa María
Germany28 sites
Katholische Stiftung Marienhospital Aachen
Aachen
Universitaetsklinikum Aachen
Aachen
St. Nikolaus-Stiftshospital GmbH
Andernach
Klinikum Bad Salzungen GmbH
Bad Salzungen
Ermstalklinik Bad Urach
Bad Urach
Charité Universitaetsklinikum (ICU medical-surgical & ICU other)
Berlin
Lungenklinik Heckeshorn
Berlin
Evangelisches Waldkrankenhaus Bad Godesberg gGmbH
Bonn
Universitaetsklinikum Bonn (ICU medical-surgical & ICU surgical)
Bonn
Carl-Thiem-Klinikum Cottbus gGmbH
Cottbus
Evangelisches Krankenhaus Elisabethenstift gGmbH
Darmstadt
Universitaetsklinikum Carl Gustav Carus
Dresden
Evangelisches Diakoniekrankenhaus
Freiburg im Breisgau
Universitaetsklinikum der Georg-August-Universitaet
Göttingen
Staedtisches Krankenhaus Martha-Maria Halle-Doelau gGmbH
Halle
Allgemeines Krankenhaus Harburg
Hamburg
Medizinische Hochschule Hannover
Hanover
Vivantes Krankenhaus am Urban
Kreuzberg
Staedtisches Klinikum Lueneburg
Lüneburg
Universitaetsklinikum
Magdeburg
Hufeland Klinikum GmbH
Mühlhausen
Dietrich-Bonhoeffer Klinikum Neubrandenburg
Neubrandenburg
Klinikum der Universitaet Regensburg
Regensburg
Ermstalklinik Staedtisches Krankenhaus Sindelfingen
Sindelfingen
Bundeswehrkrankenhaus Ulm
Ulm
Universitaetsklinikum der Martin-Luther-Universitaet Halle-Wittenberg
Wittenberg
Staedtisches Klinikum Wolfenbuttel
Wolfenbüttel
Georgius-Agricola-Klinikum Zeitz
Zeitz
Brazil23 sites
Hospital da Baleia
Belo Horizonte
Hospital da Polícia Militar
Belo Horizonte
Hospital de Pronto Socorro Risoleta Tolentino Neves
Belo Horizonte
Hospital Dia e Maternidade Unimed-BH
Belo Horizonte
Hospital Felício Rocho
Belo Horizonte
Hospital Júlia Kubitschek
Belo Horizonte
Hospital Luxemburgo
Belo Horizonte
Hospital Madre Teresa
Belo Horizonte
Hospital Nossa Senhora Aparecida
Belo Horizonte
Hospital São Francisco-Setimig
Belo Horizonte
Hospital Universitario Sao Jose
Belo Horizonte
Hospital Vera Cruz
Belo Horizonte
Hospital Vila da Serra
Belo Horizonte
Hospital Santa Rita
Contagem
Hospital São João de Deus
Divinópolis
Hospital de Messejana
Fortaleza
Hospital Universitário Walter Cantídio
Fortaleza
Hospital Universitário da Universidade Federal de Juiz de Fora
Juiz de Fora
Hospital Vaz Monteiro
Lavras
Santa Casa de Misericórdia de Ouro Preto
Ouro Preto
Hospital Arnaldo Gavazza Filho
Ponte Nova
Hospital Nossa Senhora das Graças
Sete Lagoas
Hospital São João Batista
Viçosa
Uruguay22 sites
CAAMOC Carmelo
Carmelo
Orameco
Colonia del Sacramento
Hospital de Florida
Florida
CRAMI
Las Piedras
Hospital de Maldonado
Maldonado
Sanatorio Mautone
Maldonado
Sanatorio CAMS
Mercedes
CASMU Nº2
Montevideo
Circulo Católico
Montevideo
CUDAM
Montevideo
Hospital de Clínicas
Montevideo
Hospital Español
Montevideo
Hospital Evangélico
Montevideo
Hospital Maciel
Montevideo
Hospital Pasteur
Montevideo
Hospital Policial
Montevideo
Impassa
Montevideo
Sanatorio Americano
Montevideo
CAAMEPA
Pando
COMEPA
Paysandú
Hospital Escuela del Litoral
Paysandú
Sanatorio Cantegril
Punta del Este
Australia20 sites
Calvary Wakefield Hospital
Adelaide
Flinders Medical Center
Adelaide
Ballarat Health Services
Ballarat
Bendigo Hospital
Bendigo
Mater Health Services
Brisbane
Canberra Hospital
Canberra
Royal Darwin Hospital
Darwin
Barwon Health, Geelong Hospital
Geelong
Royal Hobart Hospital
Hobart
Liverpool Hospital
Liverpool
Alfred Hospital
Melbourne
Royal Melbourne Hospital
Melbourne
St Vincent's Hospital
Melbourne
The Northern Hospital
Melbourne
The Western Hospital
Melbourne
Central Gippsland Hospital
Sale
Concord Hospital
Sydney
Nepean Hospital
Sydney
St George Hospital
Sydney
St Vincent's Hospital
Sydney
Colombia19 sites
Clínica General del Norte
Barranquilla
Clínica Fundadores
Bogotá
Clínica Shaio
Bogotá
Grupo Cimca Hospital de San José (medical ICU)
Bogotá
Grupo Cimca Hospital de Suba
Bogotá
Grupo Cimca Hospital San José
Bogotá
Hospital Santa Clara
Bogotá
Fundación cardiovascular colombiana
Bucaramanga
Centro Medico Imbanaco
Cali
Clínica Fundación Valle Lili
Cali
Nuevo Hospital Bocagrande
Cartagena
Hospital Federico Lleras Acosta
Ibague
Hospital San Rafael
Itagüí
Clinica Universitaria Bolivariana
Medellín
Clínica Cardiovascular
Medellín
Clínica Las Américas
Medellín
Clínica Medellín & Universidad Pontificia Bolivariana
Medellín
Corbic
Medellín
Hospital General de Medellín
Medellín
United States18 sites
Boston Medical Center
Boston, Massachusetts, 02118
Henry Ford Hospital Detroit
Detroit, Michigan, 48202
University Of Texas Medical Branch at Galveston
Galveston, Texas, 77555
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Louisville School of Medicine
Louisville, Kentucky, 40202
Medical College Of Wisconsin
Milwaukee, Wisconsin, 53226
Morristown Medical Center
Morristown, New Jersey, 07960
Vanderbilt University School Of Medicine
Nashville, Tennessee, 37232
The Mount Sinai Medical Center
New York, New York, 10029
Bronx Lebanon Hospital Center
New York, New York, 10457
New York Methodist Hospital
New York, New York, 11215
UMDNJ-New Jersey Medical School
Newark, New Jersey, 07101
Oklahoma City VA Medical Center
Oklahoma City, Oklahoma, 73104
Oklahoma University Health Science Center & VA medical Center
Oklahoma City, Oklahoma, 73104
Omaha VA Medical Center
Omaha, Nebraska, 68105
University Hospital San Antonio and South Texas Veterans Health Care System
San Antonio, Texas, 78229
Baystate Medical Center
Springfield, Massachusetts, 01199
Temple Clinic, Scott & White Healthcare
Temple, Texas, 76508
India16 sites
Kalinga Hospital
Bhubaneswar
Apollo Hospitals
Chennai
Artemis Health Institute
Gūrgaon
CHL Apollo Hospital
Indore
Tata Main Hospital
Jamshedpur
AMRI Hospitals Kolkata
Kolkata
Calcutta medical research institute (CMRI)
Kolkata
Calcutta Medical Research Institute
Kolkata
Kasturba Medical College
Manipal
Bombay Hospital Institute of Medical Sciences
Mumbai
Hinduja Hospital
Mumbai
Saifee Hospital
Mumbai
Tata Memorial Hospital
Mumbai
Ruby Hall Clinic
Pune
CARE Hospitals
Surat
Spandan Multispeciality Hospital
Vadodara
Italy15 sites
Ospedale Policlinico, Università Di Bari
Bari
Policlinico Universitario "S. Orsola-Malpighi"
Bologna
Ospedale "San Giovanni Di Dio"
Florence
Ospedale "Santa Maria Annunziata"
Florence
Fondazione IRCCS "Cà Grande" Ospedale Maggiore Policlinico, Università Di Milano
Milan
Ospedale "San Gerardo", Università Di Milano Bicocca
Monza
Ospedale "V. Monaldi"
Naples
Ospedale Policlinico "Federico II", Università Di Napoli
Naples
Ospedale Maggiore Della Carità, Università Del Piemonte Orientale "Amedeo Avogadro"
Novara
Ospedale "Arnas Civico, Di Cristina, Benfratelli"
Palermo
Policlinico "P. Giaccone", Università Di Palermo
Palermo
Fondazione IRCCS Policlinico "S. Matteo", Università Di Pavia (ICU 1 & ICU 2)
Pavia
Policlinico "Agostino Gemelli", Università Cattolica Del Sacro Cuore
Roma
Policlinico "Umberto I", Università La Sapienza
Roma
Ospedale "San Giovanni Battista - Molinette", Università Di Torino
Torino
Mexico15 sites
Centenario Hospital Miguel Hidalgo
Aguascalientes
Hospital Regional de Pemex
Ciudad Madero
Hospital Mérida Yucatán
Mérida
Hospital General de México
Mexico City
Instituto Nacional De Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City
Hospital Juárez de México
México DF
Hospital Regional 1° de Octubre, ISSSTE
México DF
Hospital Regional de Zona No.1 del IMSS
México DF
Hospital Ángeles de las Lomas
México DF
Instituto Nacional de Cancerología
México DF
Umae Hospital De Especialidades Dr. Antonio Fraga Mouret
México DF
Centro Médico ABC
México, DF
Hospital Español de México
Miguel Hidalgo
Hospital Universitario de Nuevo León 'Dr. Eleuterio González'
Nuevo León
Hospital Regional de Alta Especialidad de la Mujer
Villahermosa
Ecuador12 sites
Hospital José Carrasco Arteaga
Cuenca
Hospital Luis Vernaza
Guayaquil
Hospital San Vicente de Paul
Ibarra
Hospital Carlos Andrade Marín
Quito
Hospital de la Policía
Quito
Hospital de los Valles
Quito
Hospital de SOLCA (ICU medical surgical & ICU medical)
Quito
Hospital Enrique Garcés
Quito
Hospital Eugenio Espejo
Quito
Hospital General de las Fuerzas Armadas
Quito
Hospital Metropolitano
Quito
Hospital Pablo Arturo Suárez
Quito
South Korea12 sites
Hospital Korea University of Ansan
Ansan
Hallym University Medical Center
Anyang
Hospital Chungbuk National University
Cheongju-si
Hospital Chuncheon Sacred Heart Hospital, Hallym University Medical Center
Chuncheon
Hospital Catholic University of Daegu
Daegu
Hospital Dongguk University of Gyeongju
Gyeongju
Asan Medical Center, University of Ulsan
Seoul
Hospital Ewha Womans University Mokdong
Seoul
Hospital Severance, Yonsei University Health System
Seoul
Samsung Medical Center, Sungkyunkwan University
Seoul
Hospital Yonsei University Wonju Christian
Wŏnju
Hospital Pusan National University of Yangsan
Yangsan
France11 sites
Hôpital d'Armentières
Armentières
Centre Hospitalier de Châlons en Champagne
Châlons-en-Champagne
CHU Henri Mondor
Créteil
CHU d'Angers
d'Angers
CHU De Grenoble
Grenoble
Centre Hospitalier Du Mans
Le Mans
Hôpital Édouard Herriot
Lyon
Centre Hospitalier De Montauban
Montauban
Centre Hospitalier De Roanne
Roanne
CHU Charles Nicolle
Rouen
Centre Hospitalier De Saint-Malo
St-Malo
Canada10 sites
William Osler Health Science Centre
Brampton, Ontario
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia
Saint Joseph Hospital
Hamilton, Ontario
Ottawa Hospital
Ottawa, Ontario
Mount Sinai Hospital
Toronto, Ontario
Saint Michael´s Hospital
Toronto, Ontario
Sunnybrook Health Science Centre
Toronto, Ontario
Toronto General Hospital
Toronto, Ontario
Toronto Hospital Western Division
Toronto, Ontario
Toronto Western Hospital
Toronto, Ontario
Portugal10 sites
Hospital Garcia de Orta
Almada
Hospital da Luz
Amadora
Hospital de Cascais
Cascais
Centro Hospitalar de Lisboa Central
Lisbon
Centro Hospitalar de Lisboa Norte
Lisbon
Hospital de Santo Antonio dos Capuchos, Centro Hospitalar de Lisboa Central, E.P.E.
Lisbon
Centro Hospitalar Do Porto - Hospital Geral De Santo António
Porto
Instituto Português de Oncología Francisco Gentil
Porto
Hospital De São Sebastião
Seide
Centro Hospitalar Trás-Os-Montes E Alto Douro
Vila Real
Netherlands8 sites
Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam
Vrije Universiteit Medisch Centrum (VUMC) (Three units)
Amsterdam
Kennemer Gasthuis
Haarlem
Tjongerschans Ziekenhuis
Heerenveen
Spaarneziekenhuis
Hoofddorp
Medical Center Leeuwarden (MCL)
Leeuwarden
Universitair Medisch Centrum Maastricht
Maastricht
Medisch Centrum Haaglanden
The Hague
Turkey (Türkiye)8 sites
Uludag University Faculty of Medicine
Bursa
Erciye Üniversity
Erciyes
Anadolu Medical Center Istanbul
Istanbul
Atatürk Hospital
Izmir
Sutcu İmam University
Kahramanmaraş
Kirikkale University
Kirikkale
Faculty of Medicine Mersin University
Mersin
Medical Faculty of Yuzuncu Yil University
Van
New Zealand7 sites
CVICU Auckland City Hospital
Auckland
DCCM Auckland City Hospital
Auckland
Middlemore
Auckland
Christchurch Hospital
Christchurch
Waikato
Hamilton
Tauranga Hospital
Tauranga
Wellington Hospital
Wellington
Denmark6 sites
Holbak
Holbæk
Koge
Køge
Naestved
Næstved
Nykobing Falster
Nykøbing Falster
Roskilde
Roskilde
Slagelse
Slagelse
Tunisia5 sites
Hospital Abderrahmane Mami
Aryanah
Hospital Taher Sfar City
Mahdia
Hospital Fattouma Bourguina (ICU medical & ICU surgical)
Monastir
CHU Habib Bourguiba
Sfax
Hospital Universitarie Farhat Hached
Sousse
Greece4 sites
Agios Pavlos General Hospital
Thessaloniki
Ahepa Hospital
Thessaloniki
Gennimata Hospital
Thessaloniki
Papageorgiou Hospital
Thessaloniki
Russia4 sites
City Hospital Number 1 of Arkhangelsk
Arkhangelsk
Hospital No.7
Moscow
National Institute Of Surgery Named After A.V. Vishnevskij
Moscow
Hospital No.14
Yekaterinburg
Venezuela4 sites
Hospital Centro de Especialidades
Anzoátegui
Hospital Clínico Universitario
Caracas
Hospital de Clínicas
Caracas
Hospital Miguel Pérez Carreño
Caracas
Chile3 sites
Hospital de Copiapo
Copiapó
Hospital de Coquimbo
Coquimbo
Instituto Nacional del Tórax
Santiago
Morocco3 sites
Hôpital des Specialites
Rabat
Hôpital Ibn Sina (Three units)
Rabat
Hôpital Militaire D'Instruction Mohamed V
Rabat
Peru2 sites
Hospital Edgardo Rebagliatti Martins
Lima
Hospital Guillermo Almenara Irigoyen
Lima
Saudi Arabia1 site
King Saud Bin Abdulaziz University for Health Sciences
Riyadh
About this study
Official title: 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:
- Main analysis: To know the all-cause mortality rate in mechanically ventilated patients
- 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
Read the 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.
- Conditions
- Acute Respiratory Failure
- Keywords
- mechanical ventilation, epidemiology, outcomes, mortality, weaning, sedation, non-invasive positive pressure ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
All-cause Mortality
Mortality at discharge from intensive care unit
Measured: At day 28 after the beginning of mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Getafe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andres Esteban, Hospital Universitario Getafe
- Investigators
- Andres Esteban, MD, PhD, Study director, Hospital Universitario de Getafe, SpainFernando Frutos-Vivar, MD, Principal investigator, Hospital Universitario de Getafe, SpainNiall D Ferguson, MD, MsC, Principal investigator, University of TorontoAntonio Anzueto, MD, Principal investigator, University of Texas Health Science Center, San Antonio, Texas, USAMarco González, MD, Principal investigator, Clinica Medellin & Universidad Pontificia Bolivariana, ColombiaArnaud W Thille, MD, Principal investigator, AP-HP, Centre Hospitalier Albert Chenevier, Henri Mondor, Créteil, FranceKonstantinos Raymondos, MD, Principal investigator, Hannover Medical SchoolSalvatore Maggiore, MD, Principal investigator, Agostino Gemelli University Hospital, Università Cattolica del Sacro Cuore, Rome, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093482
- Sponsor's protocol ID
- ISMV-2010
- Acronym
- ISMV
- Status last verified
- Feb 2018
- First submitted
- 23 Mar 2010
- Last updated
- 1 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 11790214Esteban A, Ferguson ND, Meade MO, Frutos-Vivar F, Apezteguia C, Brochard L, Raymondos K, Nin N, Hurtado J, Tomicic V, Gonzalez M, Elizalde J, Nightingale P, Abroug F, Pelosi P, Arabi Y, Moreno R, Jibaja M, D'Empaire G, Sandi F, Matamis D, Montanez AM, Anzueto A; VENTILA Group. Evolution of mechanical ventilation in response to clinical research. Am J Respir Crit Care Med. 2008 Jan 15;177(2):170-7. doi: 10.1164/rccm.200706-893OC. Epub 2007 Oct 25.
PubMed 17962636Nin N, Muriel A, Penuelas O, Brochard L, Lorente JA, Ferguson ND, Raymondos K, Rios F, Violi DA, Thille AW, Gonzalez M, Villagomez AJ, Hurtado J, Davies AR, Du B, Maggiore SM, Soto L, 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, Sznajder JI, Esteban A; VENTILA Group. Severe hypercapnia and outcome of mechanically ventilated patients with moderate or severe acute respiratory distress syndrome. Intensive Care Med. 2017 Feb;43(2):200-208. doi: 10.1007/s00134-016-4611-1. Epub 2017 Jan 20.
PubMed 28108768Esteban 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.
PubMed 23631814
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Third Prospective, Observational, International, Multicenter Study on Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT01093482
- Acronym / sponsor ID
- ISMV / ISMV-2010
- Conditions
- Acute Respiratory Failure
- Keywords
- mechanical ventilation, epidemiology, outcomes, mortality, weaning, sedation, non-invasive positive pressure ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,151 participants (actual)
- Lead sponsor
- Hospital Universitario GetafeUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 25 Mar 2010 (estimated)
- Results
- Posted 26 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to obtain a better understanding of the spectrum of use of mechanical ventilation in intensive care units:
- Main analysis: To know the all-cause mortality rate in mechanically ventilated patients
- 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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated patients
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients less than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause Mortality
Time frame: At day 28 after the beginning of mechanical ventilation
Mortality at discharge from intensive care unit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11790214Esteban 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.
- Background: PubMed 17962636Esteban A, Ferguson ND, Meade MO, Frutos-Vivar F, Apezteguia C, Brochard L, Raymondos K, Nin N, Hurtado J, Tomicic V, Gonzalez M, Elizalde J, Nightingale P, Abroug F, Pelosi P, Arabi Y, Moreno R, Jibaja M, D'Empaire G, Sandi F, Matamis D, Montanez AM, Anzueto A; VENTILA Group. Evolution of mechanical ventilation in response to clinical research. Am J Respir Crit Care Med. 2008 Jan 15;177(2):170-7. doi: 10.1164/rccm.200706-893OC. Epub 2007 Oct 25.
- Derived from this study: PubMed 28108768Nin N, Muriel A, Penuelas O, Brochard L, Lorente JA, Ferguson ND, Raymondos K, Rios F, Violi DA, Thille AW, Gonzalez M, Villagomez AJ, Hurtado J, Davies AR, Du B, Maggiore SM, Soto L, 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, Sznajder JI, Esteban A; VENTILA Group. Severe hypercapnia and outcome of mechanically ventilated patients with moderate or severe acute respiratory distress syndrome. Intensive Care Med. 2017 Feb;43(2):200-208. doi: 10.1007/s00134-016-4611-1. Epub 2017 Jan 20.
- Derived from this study: PubMed 23631814Esteban 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andres Esteban, MD, PhD study director
Hospital Universitario de Getafe, Spain
Fernando Frutos-Vivar, MD principal investigator
Hospital Universitario de Getafe, Spain
Niall D Ferguson, MD, MsC principal investigator
University of Toronto
477 sites in 38 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure, run by Hospital Universitario Getafe at 477 sites in 38 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 477 sites in Spain, China, Argentina, Germany, Brazil and 33 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause Mortality (time frame: At day 28 after the beginning of mechanical ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01093482, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.