Prevention of Ventilator-Associated Pneumonia by Automatic Control of the Tracheal Tube Cuff Pressure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ventilator-Associated Pneumonia
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 142
- Locations
- 1
- Primary Endpoint
- Incidence of ventilator-associated pneumonia
- Status
- Completed
- Last Updated
- 19 years ago
Overview
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.
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Incidence of ventilator-associated pneumonia