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

This study has been completed.
Sponsor:
Information provided by:
Poissy-Saint Germain Hospital
ClinicalTrials.gov Identifier:
NCT00219661
First received: September 12, 2005
Last updated: April 20, 2007
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
ICU's Patients Under Mechanical Ventilation
Procedure: drainage of subglottic secretions (HiLo Evac tube)
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Poissy-Saint Germain Hospital:

Primary Outcome Measures:
  • Incidence of ventilator-associated pneumonia(VAP)

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 440
Study Start Date: June 2003
Study Completion Date: September 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00219661

Locations
France
Avignon Hospital
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
Sponsors and Collaborators
Poissy-Saint Germain Hospital
Investigators
Principal Investigator: Jean-Claude Lacherade, M.D. Medical Intensive Care Unit, Poissy-Saint-Germain Hospital
  More Information

No publications provided by Poissy-Saint Germain Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00219661     History of Changes
Other Study ID Numbers: 323
Study First Received: September 12, 2005
Last Updated: April 20, 2007
Health Authority: France: Ministry of Health

Keywords provided by Poissy-Saint Germain Hospital:
randomised control trial
intensive care unit
mechanical ventilation
ventilator-associated pneumonia
drainage of subglottic secretions

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury

ClinicalTrials.gov processed this record on August 18, 2014