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

Primary Purpose

Ventilator-Associated Pneumonia, Mechanical Ventilation

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Automatic control of tracheal tube cuff pressure

About this trial

This is an interventional prevention trial for Ventilator-Associated Pneumonia focused on measuring Ventilator-associated pneumonia, Mechanical ventilation, Tracheal tube cuff pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Servei de Pneumologia, Hospital Clinic

Outcomes

Primary Outcome Measures

Incidence of ventilator-associated pneumonia

Secondary Outcome Measures

Full Information

NCT ID

NCT00364299

First Posted

August 11, 2006

Last Updated

October 19, 2006

Sponsor

Hospital Clinic of Barcelona

Collaborators

Fondo de Investigacion Sanitaria, Sociedad Española de Neumología y Cirugía Torácica

1. Study Identification

Unique Protocol Identification Number

NCT00364299

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2006

Overall Recruitment Status

Completed

Study Start Date

October 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

May 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital Clinic of Barcelona

Collaborators

Fondo de Investigacion Sanitaria, Sociedad Española de Neumología y Cirugía Torácica

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ventilator-Associated Pneumonia, Mechanical Ventilation

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

142 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Automatic control of tracheal tube cuff pressure

Primary Outcome Measure Information:

Title

Incidence of ventilator-associated pneumonia

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Miquel Ferrer, MD

Organizational Affiliation

Hospital Clinic, Barcelona,Spain.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Servei de Pneumologia, Hospital Clinic

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

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

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