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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00364299
Enrollment
142
Registered
2006-08-15
Start date
2002-10-31
Completion date
2006-05-31
Last updated
2006-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation, Ventilator-Associated Pneumonia

Keywords

Ventilator-associated pneumonia, Mechanical ventilation, Tracheal tube cuff pressure

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.

Interventions

DEVICEAutomatic control of tracheal tube cuff pressure

Sponsors

Fondo de Investigacion Sanitaria
CollaboratorOTHER
Sociedad Española de Neumología y Cirugía Torácica
CollaboratorOTHER
Hospital Clinic of Barcelona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Incidence of ventilator-associated pneumonia

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026