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

ICU's Patients Under Mechanical Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00219661
• Other study ID #: 323
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: April 20, 2007
• Start date: June 2003
• Est. completion date: September 2006

Study information

• Verified date: April 2007
• Source: Poissy-Saint Germain Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ICU's Patients Under Mechanical Ventilation
• Pneumonia
• Pneumonia, Ventilator-Associated

Intervention

Procedure:
• drainage of subglottic secretions (HiLo Evac tube)

Locations

Country	Name	City	State
France	Avignon Hospital	Avignon
France	André Mignot Hospital	Le Chesnay
France	Poissy Saint-Germain Hospital	Poissy
France	Poisyy Saint-Germain Hospital	Saint-Germain en Laye

Sponsors (1)

Lead Sponsor	Collaborator
Poissy-Saint Germain Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of ventilator-associated pneumonia(VAP)
Secondary	Duration on mechanical ventilation (MV)
Secondary	Prior duration of MV before occurrence of VAP
Secondary	duration of ICU's stay
Secondary	Rate of tracheotomy
Secondary	ICU's mortality
Secondary	Microbiology of the VAP