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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00364299
Other study ID # FIS 020744
Secondary ID
Status Completed
Phase N/A
First received August 11, 2006
Last updated October 19, 2006
Start date October 2002
Est. completion date May 2006

Study information

Verified date May 2006
Source Hospital Clinic of Barcelona
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 142
Est. completion date May 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Device:
Automatic control of tracheal tube cuff pressure


Locations

Country Name City State
Spain Servei de Pneumologia, Hospital Clinic Barcelona

Sponsors (3)

Lead Sponsor Collaborator
Hospital Clinic of Barcelona Fondo de Investigacion Sanitaria, Sociedad Española de Neumología y Cirugía Torácica

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of ventilator-associated pneumonia
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