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Clinical Trial Summary

The study aims to assess early (one to three days after intubation) tracheostomy effectiveness in terms of reduction in ventilator associated pneumonia (VAP) incidence.


Clinical Trial Description

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. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT00262431
Study type Interventional
Source University of Turin, Italy
Contact
Status Completed
Phase Phase 3
Start date June 2004
Completion date October 2008

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