Prevention of Ventilator-Associated Pneumonia by Automatic Control of the Tracheal Tube Cuff Pressure - Full Text View

Sponsors and Collaborators:	Hospital Clinic of Barcelona Fondo de Investigacion Sanitaria Sociedad Española de Neumología y Cirugía Torácica
Information provided by:	Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:	NCT00364299

Purpose

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.

Condition	Intervention
Ventilator-Associated Pneumonia Mechanical Ventilation	Device: Automatic control of tracheal tube cuff pressure

MedlinePlus related topics: Pneumonia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Prevention of Ventilator-Associated Pneumonia by Automatic Control of the Tracheal Tube Cuff Pressure

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:

Incidence of ventilator-associated pneumonia

Estimated Enrollment:	142
Study Start Date:	October 2002
Estimated Study Completion Date:	May 2006

Detailed Description:

Design: Prospective, randomized, controlled trial, with 2 groups: study (automated control of cuff pressure) and control (standard control of cuff pressure). Setting: Respiratory Intensive Care Unit (RICU). Subjects: Patients >18 yr, intubated and ventilated. Interventions and measurements: Study group (cuff pressure will be kept constant at 25 cmH2O with the automatic device) and control group (cuff pressure control every 8 h. at the same level using a manual pressure controller, according with standard routine); recording of clinical variables at admission and during RICU stay, and end-point variables (incidence of VAP, etiologic microorganisms, RICU and hospital stay, RICU and 60-d mortality. Expected results: Lower incidence of VAP in study group, compared with control group.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Pneumonia
Witnessed macroscopic aspiration

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364299

Locations

Spain
Servei de Pneumologia, Hospital Clinic
Barcelona, Spain, 08036

Sponsors and Collaborators

Hospital Clinic of Barcelona

Fondo de Investigacion Sanitaria

Sociedad Española de Neumología y Cirugía Torácica

Investigators

Principal Investigator:

Miquel Ferrer, MD

Hospital Clinic, Barcelona,Spain.

More Information

Study ID Numbers:	FIS 020744
Study First Received:	August 11, 2006
Last Updated:	October 19, 2006
ClinicalTrials.gov Identifier:	NCT00364299
Health Authority:	Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Clinic of Barcelona:

Ventilator-associated pneumonia
Mechanical ventilation
Tracheal tube cuff pressure

Study placed in the following topic categories:

Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases

Pneumonia, Ventilator-Associated
Cross Infection
Pneumonia

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on January 14, 2009