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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
Information provided by:

Study Description
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
Ventilator-Associated Pneumonia Mechanical Ventilation Device: Automatic control of tracheal tube cuff pressure

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

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated 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

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00364299

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
Principal Investigator: Miquel Ferrer, MD Hospital Clinic, Barcelona,Spain.
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, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Ventilator-Induced Lung Injury
Lung Injury