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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01093482




Registration number
NCT01093482
Ethics application status
Date submitted
23/03/2010
Date registered
25/03/2010
Date last updated
1/03/2018

Titles & IDs
Public title
Third International Study on Mechanical Ventilation
Scientific title
Third Prospective, Observational, International, Multicenter Study on Mechanical Ventilation
Secondary ID [1] 0 0
ISMV-2010
Universal Trial Number (UTN)
Trial acronym
ISMV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Respiratory Failure 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
mechanically ventilated patients - Patients who are admitted to the participating intensive care units and require invasive mechanical ventilation (endotracheal tube or tracheostomy) for more than 12 hours.
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.

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All-cause Mortality - Mortality at discharge from intensive care unit
Timepoint [1] 0 0
At day 28 after the beginning of mechanical ventilation

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients less than 18 years old

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Calvary Wakefield Hospital - Adelaide
Recruitment hospital [2] 0 0
Flinders Medical Center - Adelaide
Recruitment hospital [3] 0 0
Ballarat Health Services - Ballarat
Recruitment hospital [4] 0 0
Bendigo Hospital - Bendigo
Recruitment hospital [5] 0 0
Mater Health Services - Brisbane
Recruitment hospital [6] 0 0
Canberra Hospital - Canberra
Recruitment hospital [7] 0 0
Royal Darwin Hospital - Darwin
Recruitment hospital [8] 0 0
Barwon Health, Geelong Hospital - Geelong
Recruitment hospital [9] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [10] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [11] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [12] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [13] 0 0
St Vincent's Hospital - Melbourne
Recruitment hospital [14] 0 0
The Northern Hospital - Melbourne
Recruitment hospital [15] 0 0
The Western Hospital - Melbourne
Recruitment hospital [16] 0 0
Central Gippsland Hospital - Sale
Recruitment hospital [17] 0 0
Concord Hospital - Sidney
Recruitment hospital [18] 0 0
Nepean Hospital - Sidney
Recruitment hospital [19] 0 0
St George Hospital - Sidney
Recruitment hospital [20] 0 0
St Vincent's Hospital - Sidney
Recruitment postcode(s) [1] 0 0
- Adelaide
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- Ballarat
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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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- Sale
Recruitment postcode(s) [12] 0 0
- Sidney
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United States of America
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Iowa
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Kentucky
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Massachusetts
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Michigan
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Funding & Sponsors
Primary sponsor type
Other
Name
Hospital Universitario Getafe
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/show/NCT01093482
Trial related presentations / publications
Esteban A, Anzueto A, Frutos F, Alía I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguía 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.
Esteban A, Ferguson ND, Meade MO, Frutos-Vivar F, Apezteguia C, Brochard L, Raymondos K, Nin N, Hurtado J, Tomicic V, González M, Elizalde J, Nightingale P, Abroug F, Pelosi P, Arabi Y, Moreno R, Jibaja M, D'Empaire G, Sandi F, Matamis D, Montañez 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. Epub 2007 Oct 25. Review.
Public notes

Contacts
Principal investigator
Name 0 0
Andres Esteban, MD, PhD
Address 0 0
Hospital Universitario de Getafe, Spain
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications