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

This study has been completed.

Sponsor:

Collaborators:

Fondo de Investigacion Sanitaria

Sociedad Española de Neumología y Cirugía Torácica

Information provided by:

Hospital Clinic of Barcelona

ClinicalTrials.gov Identifier:

NCT00364299

First received: August 11, 2006

Last updated: October 19, 2006

Last verified: May 2006

History of Changes

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Prevention of Ventilator-Associated Pneumonia by Automatic Control of the Tracheal Tube Cuff Pressure

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

U.S. FDA Resources

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided


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

Keywords provided by Hospital Clinic of Barcelona:


Ventilator-associated pneumonia Mechanical ventilation Tracheal tube cuff pressure

Additional relevant MeSH terms:


Pneumonia Pneumonia, Ventilator-Associated Cross Infection Infection Lung Diseases	Lung Injury Respiratory Tract Diseases Respiratory Tract Infections Ventilator-Induced Lung Injury

ClinicalTrials.gov processed this record on March 03, 2015

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