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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2006-05-31

Brief Summary

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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

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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.

Conditions

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Ventilator-Associated Pneumonia Mechanical Ventilation

Keywords

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Ventilator-associated pneumonia Mechanical ventilation Tracheal tube cuff pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Automatic control of tracheal tube cuff pressure

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Miquel Ferrer, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic, Barcelona,Spain.

Locations

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Servei de Pneumologia, Hospital Clinic

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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FIS 020744

Identifier Type: -

Identifier Source: org_study_id