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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01093482
Registration number
NCT01093482
Ethics application status
Date submitted
23/03/2010
Date registered
25/03/2010
Titles & IDs
Public title
Third International Study on Mechanical Ventilation
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Scientific title
Third Prospective, Observational, International, Multicenter Study on Mechanical Ventilation
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Secondary ID [1]
0
0
ISMV-2010
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Universal Trial Number (UTN)
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Trial acronym
ISMV
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Respiratory Failure
0
0
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Condition category
Condition code
Respiratory
0
0
0
0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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All-cause Mortality
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Assessment method [1]
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Mortality at discharge from intensive care unit
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Timepoint [1]
0
0
At day 28 after the beginning of mechanical ventilation
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Patients less than 18 years old
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2010
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Sample size
Target
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Accrual to date
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Final
8151
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Calvary Wakefield Hospital - Adelaide
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Recruitment hospital [2]
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Flinders Medical Center - Adelaide
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Recruitment hospital [3]
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Ballarat Health Services - Ballarat
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Recruitment hospital [4]
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Bendigo Hospital - Bendigo
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Recruitment hospital [5]
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Mater Health Services - Brisbane
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Recruitment hospital [6]
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Canberra Hospital - Canberra
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Recruitment hospital [7]
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Royal Darwin Hospital - Darwin
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Recruitment hospital [8]
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Barwon Health, Geelong Hospital - Geelong
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Recruitment hospital [9]
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Royal Hobart Hospital - Hobart
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Recruitment hospital [10]
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Liverpool Hospital - Liverpool
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Recruitment hospital [11]
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Alfred Hospital - Melbourne
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Recruitment hospital [12]
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Royal Melbourne Hospital - Melbourne
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Recruitment hospital [13]
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St Vincent's Hospital - Melbourne
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Recruitment hospital [14]
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The Northern Hospital - Melbourne
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Recruitment hospital [15]
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The Western Hospital - Melbourne
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Recruitment hospital [16]
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Central Gippsland Hospital - Sale
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Recruitment hospital [17]
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Concord Hospital - Sidney
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Recruitment hospital [18]
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Nepean Hospital - Sidney
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Recruitment hospital [19]
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St George Hospital - Sidney
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Recruitment hospital [20]
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St Vincent's Hospital - Sidney
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment postcode(s) [2]
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- Ballarat
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Recruitment postcode(s) [3]
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- Bendigo
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- Brisbane
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- Canberra
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- Darwin
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- Geelong
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- Hobart
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- Liverpool
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- Melbourne
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Recruitment postcode(s) [11]
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- Sale
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Recruitment postcode(s) [12]
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- Sidney
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Recruitment outside Australia
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Iowa
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Massachusetts
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Nebraska
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Oklahoma
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Texas
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Wisconsin
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Argentina
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Córdoba
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General Roca
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Haedo
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Temperley
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Argentina
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Vicente López
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Brazil
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Brazil
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Nova Scotia
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Canada
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Ontario
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Chile
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Chile
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Coquimbo
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Santiago
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Guangzhou
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Haining
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China
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Kunming
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China
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China
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Wuxi
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China
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Xi'an
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China
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Xuzhou
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China
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Yantai
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Colombia
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Barranquilla
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Ibague
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Itagui
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Colombia
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Medellín
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Denmark
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Holbaek
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Koge
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Naestved
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Denmark
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Nykobing Falster
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Roskilde
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Denmark
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Slagelse
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Ecuador
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Cuenca
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Ecuador
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Ecuador
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Ecuador
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Egypt
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Cairo
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Armentieres
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France
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Le Mans
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France
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Lyon
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Caracas
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Vietnam
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Hanoi
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Funding & Sponsors
Primary sponsor type
Other
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Name
Hospital Universitario Getafe
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/study/NCT01093482
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Trial related presentations / 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. Esteban 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. Nin 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. Esteban A, Frutos-Vivar F, Muriel A, Ferguson ND, Penuelas O, Abraira V, Raymondos K, Rios F, Nin N, Apezteguia C, Violi DA, Thille AW, Brochard L, Gonzalez M, Villagomez AJ, Hurtado J, Davies AR, Du B, Maggiore SM, Pelosi P, Soto L, Tomicic V, D'Empaire G, Matamis D, Abroug F, Moreno RP, Soares MA, Arabi Y, Sandi F, Jibaja M, Amin P, Koh Y, Kuiper MA, Bulow HH, Zeggwagh AA, Anzueto A. Evolution of mortality over time in patients receiving mechanical ventilation. Am J Respir Crit Care Med. 2013 Jul 15;188(2):220-30. doi: 10.1164/rccm.201212-2169OC.
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Public notes
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Contacts
Principal investigator
Name
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0
Andres Esteban, MD, PhD
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Address
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Hospital Universitario de Getafe, Spain
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01093482