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Third International Study on Mechanical Ventilation

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01093482
Acronym
ISMV
Enrollment
8151
Registered
2010-03-25
Start date
2010-04-30
Completion date
2010-09-30
Last updated
2018-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure

Keywords

mechanical ventilation, epidemiology, outcomes, mortality, weaning, sedation, non-invasive positive pressure ventilation

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

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.

Interventions

None listed

Sponsors

Hospital Universitario Getafe
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
All-cause MortalityAt day 28 after the beginning of mechanical ventilationMortality at discharge from intensive care unit

Countries

Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Denmark, Ecuador, Egypt, France, Germany, Greece, Hungary, India, Italy, Japan, Mexico, Morocco, Netherlands, New Zealand, Panama, Peru, Poland, Portugal, Puerto Rico, Russia, Saudi Arabia, South Korea, Spain, Taiwan, Tunisia, Turkey (Türkiye), United States, Uruguay, Venezuela, Vietnam

Participant flow

Recruitment details

Consecutive patients who required mechanical ventilation for more than 12 hours in the participating intensive care units.

Participants by arm

ArmCount
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.
8,151
Total8,151

Baseline characteristics

CharacteristicMechanically Ventilated Patients
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
3918 Participants
Age, Categorical
Between 18 and 65 years
4233 Participants
Age, Continuous61 years
STANDARD_DEVIATION 18
Sex: Female, Male
Female
3105 Participants
Sex: Female, Male
Male
5046 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
2,269 / 8,151
other
Total, other adverse events
0 / 8,151
serious
Total, serious adverse events
0 / 8,151

Outcome results

Primary

All-cause Mortality

Mortality at discharge from intensive care unit

Time frame: At day 28 after the beginning of mechanical ventilation

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mechanically Ventilated PatientsAll-cause Mortality2269 Participants

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026