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Sponsors and Collaborators: |
University of Turin, Italy Regione Piemonte |
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Information provided by: | University of Turin, Italy |
ClinicalTrials.gov Identifier: | NCT00262431 |
The study aims to assess early (one to three days after intubation) tracheostomy effectiveness in terms of reduction in ventilator associated pneumonia (VAP) incidence.
Condition | Intervention | Phase |
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Respiratory Insufficiency |
Procedure: Tracheostomy on day 3-5 in early group and 10-12 in late group |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 320 |
Study Start Date: | June 2004 |
Study Completion Date: | October 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Early (A): Active Comparator
Patients of the EARLY group (A) will be submitted to tracheostomy on day 3-5 from oro/nasotracheal intubation.
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Procedure: Tracheostomy on day 3-5 in early group and 10-12 in late group
Upon admission to ICU, acute respiratory failure patients requiring at least 3 days of mechanical ventilation and defined by a SAPS II score between 35 and 65, will be randomly assigned to either arm A or B of the study.
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Late (B): Active Comparator
Patients of the LATE group (B) will undergo tracheostomy on day 10-12 from oro/nasotracheal intubation.
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Procedure: Tracheostomy on day 3-5 in early group and 10-12 in late group
Upon admission to ICU, acute respiratory failure patients requiring at least 3 days of mechanical ventilation and defined by a SAPS II score between 35 and 65, will be randomly assigned to either arm A or B of the study.
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Tracheostomy is an essential and irreplaceable procedure for critically ill patients requiring mechanical ventilatory support and adequate airway control. The therapeutical choice of performing a tracheostomy is supported by a number of clinical benefits, such as less use of drugs for sedation, fewer days of mechanical ventilation and hence shorter Intensive Care Unit (ICU) length of stay, as well as better resource rationalization. Actually there is no agreement on the best timing for tracheostomy. The aim of this study is to verify if an early tracheostomy (one to three days after intubation) increases ventilator associated pneumonia-free days. Secondary endpoints are: increase of ventilator free-days and mortality reduction.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Immunosuppressed and/or immunodepressed patients:
Italy | |
University of Turin, Department of Anesthesia and Intensive Care Medicine | |
Turin, Italy, 10126 |
Principal Investigator: | V. M. Ranieri, MD | University of Turin |
Study Director: | V. M. Ranieri, MD | University of Turin |
Responsible Party: | University of Turin, Italy ( Marco Ranieri ) |
Study ID Numbers: | 1431/28.3 |
Study First Received: | December 5, 2005 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00262431 History of Changes |
Health Authority: | Italy: Ministry of Health |
Tracheostomy Tracheostomy timing Ventilator associated pneumonia Mechanical ventilation |
Respiratory Insufficiency Respiratory Tract Infections Respiratory Tract Diseases Lung Diseases |
Respiration Disorders Pneumonia, Ventilator-Associated Cross Infection Pneumonia |
Respiratory Insufficiency Respiratory Tract Infections Respiratory Tract Diseases Lung Diseases Respiration Disorders |
Infection Pneumonia, Ventilator-Associated Pneumonia Cross Infection |