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

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ClinicalTrials.gov Identifier: NCT00364299
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : October 20, 2006
Sponsor:
Collaborators:
Fondo de Investigacion Sanitaria
Sociedad Española de Neumología y Cirugía Torácica
Information provided by:
Hospital Clinic of Barcelona

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ventilator-Associated Pneumonia Mechanical Ventilation Device: Automatic control of tracheal tube cuff pressure Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Ventilator-Associated Pneumonia by Automatic Control of the Tracheal Tube Cuff Pressure
Study Start Date : October 2002
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Incidence of ventilator-associated pneumonia

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00364299     History of Changes
Other Study ID Numbers: FIS 020744
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: October 20, 2006
Last Verified: May 2006

Keywords provided by Hospital Clinic of Barcelona:
Ventilator-associated pneumonia
Mechanical ventilation
Tracheal tube cuff pressure

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
 Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury