- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00364299
Prevention of Ventilator-Associated Pneumonia by Automatic Control of the Tracheal Tube Cuff Pressure
October 19, 2006 updated by: Hospital Clinic of Barcelona
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
142
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Barcelona, Spain, 08036
- Servei de Pneumologia, Hospital Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Incidence of ventilator-associated pneumonia
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Miquel Ferrer, MD, Hospital Clinic, Barcelona,Spain.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2002
Study Completion
May 1, 2006
Study Registration Dates
First Submitted
August 11, 2006
First Submitted That Met QC Criteria
August 11, 2006
First Posted (Estimate)
August 15, 2006
Study Record Updates
Last Update Posted (Estimate)
October 20, 2006
Last Update Submitted That Met QC Criteria
October 19, 2006
Last Verified
May 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FIS 020744
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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