Prevention of Ventilator-Associated Pneumonia by Automatic Control of the Tracheal Tube Cuff Pressure
- Conditions
- Ventilator-Associated PneumoniaMechanical Ventilation
- Registration Number
- NCT00364299
- Lead Sponsor
- Hospital Clinic of Barcelona
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 142
- Patients older than 18 years,
- Orotracheal intubation for less than 24 hours
- Expectancy to remain on mechanical ventilation for more than 48 hours
- Pneumonia
- Witnessed macroscopic aspiration
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of ventilator-associated pneumonia
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Servei de Pneumologia, Hospital Clinic
🇪🇸Barcelona, Spain