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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| drainage of subglottic secretions (HiLo Evac tube) | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ventilator-associated pneumonia(VAP) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration on mechanical ventilation (MV) | ||
| Prior duration of MV before occurrence of VAP | ||
| duration of ICU's stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Claude Lacherade, M.D. | Medical Intensive Care Unit, Poissy-Saint-Germain Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avignon Hospital | Avignon | 84 000 | France | |||
| André Mignot Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20522796 | Derived | Lacherade JC, De Jonghe B, Guezennec P, Debbat K, Hayon J, Monsel A, Fangio P, Appere de Vecchi C, Ramaut C, Outin H, Bastuji-Garin S. Intermittent subglottic secretion drainage and ventilator-associated pneumonia: a multicenter trial. Am J Respir Crit Care Med. 2010 Oct 1;182(7):910-7. doi: 10.1164/rccm.200906-0838OC. Epub 2010 Jun 3. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 4, 2009 | |
| Reset | Mar 2, 2009 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 4, 2009 | Mar 2, 2009 |
| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
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| Rate of tracheotomy |
| ICU's mortality |
| Microbiology of the VAP |
| Le Chesnay |
| 78 |
| France |
| Poissy Saint-Germain Hospital | Poissy | 78300 | France |
| Poisyy Saint-Germain Hospital | Saint-Germain-en-Laye | 78 | France |
| D012141 |
| Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |