Prevention of Ventilator-Associated Pneumonia by Automatic Control of the Tracheal Tube Cuff Pressure
This study has been completed.
Sponsor:
Hospital Clinic of Barcelona
Collaborators:
Fondo de Investigacion Sanitaria
Sociedad Española de Neumología y Cirugía Torácica
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00364299
First received: August 11, 2006
Last updated: October 19, 2006
Last verified: May 2006
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Ventilator-Associated Pneumonia Mechanical Ventilation |
Device: Automatic control of tracheal tube cuff pressure |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Prevention of Ventilator-Associated Pneumonia by Automatic Control of the Tracheal Tube Cuff Pressure |
Resource links provided by NLM:
Further study details as provided by Hospital Clinic of Barcelona:
Primary Outcome Measures:
- Incidence of ventilator-associated pneumonia
| Estimated Enrollment: | 142 |
| Study Start Date: | October 2002 |
| Estimated Study Completion Date: | May 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00364299
Please refer to this study by its ClinicalTrials.gov identifier: NCT00364299
Locations
| Spain | |
| Servei de Pneumologia, Hospital Clinic | |
| Barcelona, Spain, 08036 | |
Sponsors and Collaborators
Hospital Clinic of Barcelona
Fondo de Investigacion Sanitaria
Sociedad Española de Neumología y Cirugía Torácica
Investigators
| Principal Investigator: | Miquel Ferrer, MD | Hospital Clinic, Barcelona,Spain. |
More Information
| ClinicalTrials.gov Identifier: | NCT00364299 History of Changes |
| Other Study ID Numbers: | FIS 020744 |
| Study First Received: | August 11, 2006 |
| Last Updated: | October 19, 2006 |
| Health Authority: | Spain: Comité Ético de Investigación Clínica |
Keywords provided by Hospital Clinic of Barcelona:
|
Ventilator-associated pneumonia Mechanical ventilation Tracheal tube cuff pressure |
Additional relevant MeSH terms:
|
Pneumonia Pneumonia, Ventilator-Associated Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Cross Infection Infection Ventilator-Induced Lung Injury Lung Injury |
ClinicalTrials.gov processed this record on September 30, 2016