NCT00364299

Brief Summary

Background: The aspiration of contaminated secretions pooled above the endotracheal tube cuff secondary to inadvertent falls of cuff pressure is the main pathogenic mechanism of ventilator-associated pneumonia (VAP). Aim of the study: To assess the efficacy of an automatic device for the continuous regulation of tracheal tube cuff pressure in decreasing the incidence of VAP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

October 1, 2002

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
Last Updated

October 20, 2006

Status Verified

May 1, 2006

First QC Date

August 11, 2006

Last Update Submit

October 19, 2006

Conditions

Ventilator-Associated PneumoniaMechanical Ventilation

Keywords

Ventilator-associated pneumoniaMechanical ventilationTracheal tube cuff pressure

Outcome Measures

Primary Outcomes (1)

  • Incidence of ventilator-associated pneumonia

Interventions

Automatic control of tracheal tube cuff pressureDEVICE

Eligibility Criteria

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

You may qualify if:

  • Patients older than 18 years,
  • Orotracheal intubation for less than 24 hours
  • Expectancy to remain on mechanical ventilation for more than 48 hours

You may not qualify if:

  • Pneumonia
  • Witnessed macroscopic aspiration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Servei de Pneumologia, Hospital Clinic

Barcelona, Barcelona, 08036, Spain

Location

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

  • Miquel Ferrer, MD

    Hospital Clinic, Barcelona,Spain.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 11, 2006

First Posted

August 15, 2006

Study Start

October 1, 2002

Study Completion

May 1, 2006

Last Updated

October 20, 2006

Record last verified: 2006-05

Locations

ES(1)