NCT00219661

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2003

Typical duration for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

April 23, 2007

Status Verified

April 1, 2007

First QC Date

September 12, 2005

Last Update Submit

April 20, 2007

Conditions

ICU's Patients Under Mechanical Ventilation

Keywords

randomised control trialintensive care unitmechanical ventilationventilator-associated pneumoniadrainage of subglottic secretions

Outcome Measures

Primary Outcomes (1)

  • Incidence of ventilator-associated pneumonia(VAP)

Secondary Outcomes (6)

  • Duration on mechanical ventilation (MV)

  • Prior duration of MV before occurrence of VAP

  • duration of ICU's stay

  • Rate of tracheotomy

  • ICU's mortality

  • +1 more secondary outcomes

Interventions

drainage of subglottic secretions (HiLo Evac tube)PROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ICU patients expected to require MV more than 48 hours

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Avignon Hospital

Avignon, 84 000, France

Location

André Mignot Hospital

Le Chesnay, 78, France

Location

Poissy Saint-Germain Hospital

Poissy, 78300, France

Location

Poisyy Saint-Germain Hospital

Saint-Germain-en-Laye, 78, France

Location

Related Publications (1)

  • 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.

    PMID: 20522796DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Claude Lacherade, M.D.

    Medical Intensive Care Unit, Poissy-Saint-Germain Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 22, 2005

Study Start

June 1, 2003

Study Completion

September 1, 2006

Last Updated

April 23, 2007

Record last verified: 2007-04

Locations

FR(4)