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

Primary Purpose

ICU's Patients Under Mechanical Ventilation

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
drainage of subglottic secretions (HiLo Evac tube)
Sponsored by
Poissy-Saint Germain Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for ICU's Patients Under Mechanical Ventilation focused on measuring randomised control trial, intensive care unit, mechanical ventilation, ventilator-associated pneumonia, drainage of subglottic secretions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Avignon Hospital
  • André Mignot Hospital
  • Poissy Saint-Germain Hospital
  • Poisyy Saint-Germain Hospital

Outcomes

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

Full Information

First Posted
September 12, 2005
Last Updated
April 20, 2007
Sponsor
Poissy-Saint Germain Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00219661
Brief Title
Effect of Drainage of Subglottic Secretions on Pneumonia Acquired Under Mechanical Ventilation
Official Title
Impact of Drainage of Subglottic Secretions on Ventilator-Associated Pneumonia:a Randomised Multicentre Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Poissy-Saint Germain Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ICU's Patients Under Mechanical Ventilation
Keywords
randomised control trial, intensive care unit, mechanical ventilation, ventilator-associated pneumonia, drainage of subglottic secretions

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
440 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
drainage of subglottic secretions (HiLo Evac tube)
Primary Outcome Measure Information:
Title
Incidence of ventilator-associated pneumonia(VAP)
Secondary Outcome Measure Information:
Title
Duration on mechanical ventilation (MV)
Title
Prior duration of MV before occurrence of VAP
Title
duration of ICU's stay
Title
Rate of tracheotomy
Title
ICU's mortality
Title
Microbiology of the VAP

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Claude Lacherade, M.D.
Organizational Affiliation
Medical Intensive Care Unit, Poissy-Saint-Germain Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Avignon Hospital
City
Avignon
ZIP/Postal Code
84 000
Country
France
Facility Name
André Mignot Hospital
City
Le Chesnay
ZIP/Postal Code
78
Country
France
Facility Name
Poissy Saint-Germain Hospital
City
Poissy
ZIP/Postal Code
78300
Country
France
Facility Name
Poisyy Saint-Germain Hospital
City
Saint-Germain en Laye
ZIP/Postal Code
78
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
20522796
Citation
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.
Results Reference
derived

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

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