An observational study in Acute Respiratory Failure, sponsored by Hospital Universitario Getafe. Completed at 477 sites in 38 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-01.
Sponsored by Hospital Universitario Getafe · Observational
The objective of this study is to obtain a better understanding of the spectrum of use of mechanical ventilation in intensive care units:
Secondary analyses:
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.
Hospital Universitario Getafe is the lead sponsor of 29 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Mechanically ventilated patients
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
All-cause Mortality
Mortality at discharge from intensive care unit
Time frame: At day 28 after the beginning of mechanical ventilation
Consecutive patients who required mechanical ventilation for more than 12 hours in the participating intensive care units.
| Milestone | Mechanically Ventilated Patients |
|---|---|
| Started | 8151 |
| Completed | 8151 |
| Not completed | 0 |
Mortality at discharge from intensive care unit
| Participants | Mechanically Ventilated Patients |
|---|---|
| All-cause Mortality | 2269 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mechanically Ventilated Patients | 2,269/8,151 (27.8%) | 0/8,151 (0%) | 0/8,151 (0%) |
| Age, Categorical(Participants) | Mechanically Ventilated Patients |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 4233 |
| >=65 years | 3918 |
| Age, Continuous(years) | Mechanically Ventilated Patients |
|---|---|
| Mean | 61 ± 18 |
| Sex: Female, Male(Participants) | Mechanically Ventilated Patients |
|---|---|
| Female | 3105 |
| Male | 5046 |
Showing the first 100 of 477 sites across 38 countries. Choose a country and city above to see the rest.
Plan to share: Undecided
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Hospital Universitario Getafe