Effect of Drainage of Subglottic Secretions on Pneumonia Acquired Under Mechanical Ventilation
The purpose of this study is to determine whether drainage of subglottic secretions is effective to reduce the incidence of pneumonia acquired under mechanical ventilation in ICU's patients.
ICU's Patients Under Mechanical Ventilation
Procedure: drainage of subglottic secretions (HiLo Evac tube)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Impact of Drainage of Subglottic Secretions on Ventilator-Associated Pneumonia:a Randomised Multicentre Trial|
- Incidence of ventilator-associated pneumonia(VAP)
- Duration on mechanical ventilation (MV)
- Prior duration of MV before occurrence of VAP
- duration of ICU's stay
- Rate of tracheotomy
- ICU's mortality
- Microbiology of the VAP
|Study Start Date:||June 2003|
|Study Completion Date:||September 2006|
Nosocomial infection represent a major problem in hospitals. In intensive care units, ventilator-associated pneumonia (VAP) is associated with an increase in morbidity and mortality. Incidence of VAP is high, 20 to 30% of patients under mechanical ventilation (MV) for more than 48 hours. In the pathogenesis of VAP, two processes are considered essential for its development: bacterial colonization of the oropharynx and tracheobronchial tract, followed by aspiration of contaminated secretions into the lower airways. It has been shown that pooled secretions above inflated endotracheal tube cuffs may be source of aspiration and can be a cause of VAP. Several studies have suggested that recurrent aspiration of subglottic secretions can be prevented by intermittent drainage of subglottic secretions. Nevertheless, recent CDC guideline reported that there was not enough evidence to conclude on the efficacy of such intervention.
During the study, patients, in both groups, will be intubated with the same device permitting subglottic drainage (HiLo Evac endotracheal tube). The daily screening of VAP will be performed until the 28th days of mechanical ventilation without occurrence of VAP. The follow-up of each patient will be realized until the ICU’s discharge.
Comparison: The incidence of VAP will be compared between two groups: one group with intermittent drainage of subglottic secretions and the other one without this intervention.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00219661
|Avignon, France, 84 000|
|André Mignot Hospital|
|Le Chesnay, France, 78|
|Poissy Saint-Germain Hospital|
|Poissy, France, 78300|
|Poisyy Saint-Germain Hospital|
|Saint-Germain en Laye, France, 78|
|Principal Investigator:||Jean-Claude Lacherade, M.D.||Medical Intensive Care Unit, Poissy-Saint-Germain Hospital|