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

April 20, 2007 updated by: Poissy-Saint Germain Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

440

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Avignon, France, 84 000
        • Avignon Hospital
      • Le Chesnay, France, 78
        • André Mignot Hospital
      • Poissy, France, 78300
        • Poissy Saint-Germain Hospital
      • Saint-Germain en Laye, France, 78
        • Poisyy Saint-Germain Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of ventilator-associated pneumonia(VAP)

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poissy-Saint Germain Hospital

Investigators

  • Principal Investigator: Jean-Claude Lacherade, M.D., Medical Intensive Care Unit, Poissy-Saint-Germain Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Study Completion (ACTUAL)

September 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (ESTIMATE)

September 22, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

April 23, 2007

Last Update Submitted That Met QC Criteria

April 20, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 323

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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