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
  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:


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

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
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury

ClinicalTrials.gov processed this record on April 17, 2014