Effect of Drainage of Subglottic Secretions on Pneumonia Acquired Under Mechanical Ventilation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Drainage of Subglottic Secretions on Ventilator-Associated Pneumonia:a Randomised Multicentre Trial

Conditions
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ICU's Patients Under Mechanical Ventilation

Intervention / Treatment
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* Procedure: drainage of subglottic secretions (HiLo Evac tube)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ICU patients expected to require MV more than 48 hours Exclusion Criteria: patients already intubated for more than 12 hours patients intubated with another tube than the HiLo Evac tube patients admitted for cardiac arrest patients admitted for self poisoning patients admitted with tracheotomy patients already included in an another clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: drainage of subglottic secretions (HiLo Evac tube)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ventilator-associated pneumonia(VAP) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomised control trial, intensive care unit, mechanical ventilation, ventilator-associated pneumonia, drainage of subglottic secretions