Third International Study on Mechanical Ventilation
Status: | Completed |
---|---|
Conditions: | Hospital, Pulmonary |
Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/17/2018 |
Start Date: | April 2010 |
End Date: | September 2010 |
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:
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
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
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.
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.
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
We found this trial at
19
sites
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Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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UMDNJ-New Jersey Medical School NJMS is committed to educating humanistic, culturally competent physicians who will...
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University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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1200 Children's Avenue
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
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4318 Woodcock Drive
San Antonio, Texas 78229
San Antonio, Texas 78229
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Baystate Medical Center Baystate Medical Center (BMC), in Springfield, Massachusetts, is an academic, research, and...
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