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

NCT ID: NCT00219661

Last Updated: 2007-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 440 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2006-09-30

Brief 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.

Detailed 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.

Conditions

ICU's Patients Under Mechanical Ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

drainage of subglottic secretions (HiLo Evac tube)

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poissy-Saint Germain Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Jean-Claude Lacherade, M.D.

Role: PRINCIPAL_INVESTIGATOR

Medical Intensive Care Unit, Poissy-Saint-Germain Hospital

Locations

Avignon Hospital

Avignon, , France

André Mignot Hospital

Le Chesnay, , France

Poissy Saint-Germain Hospital

Poissy, , France

Poisyy Saint-Germain Hospital

Saint-Germain-en-Laye, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 20522796 (View on PubMed)

Other Identifiers

323

Identifier Type: -

Identifier Source: org_study_id