NCT00262431

Efficacy of Early Tracheostomy to Reduce Incidence of Ventilator Acquired Pneumonia (VAP)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: University of Turin, Italy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Respiratory Insufficiency

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2004-06-01
• Primary completion: 2008-06-01
• Completion: 2008-10-01
• First posted: 2005-12-06
• Last updated: 2012-06-08

Locations

1 site across 1 country: Italy