Efficacy of Early Tracheostomy to Reduce Incidence of Ventilator Acquired Pneumonia (VAP)
NCT00262431 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 320
Last updated 2012-06-08
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.
Conditions
- Respiratory Insufficiency
Interventions
- 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.
Sponsors & Collaborators
-
Regione Piemonte
collaborator OTHER -
University of Turin, Italy
lead OTHER
Principal Investigators
-
V. M. Ranieri, MD · University of Turin, Italy
-
V. M. Ranieri, MD · University of Turin, Italy
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-06-30
- Primary Completion
- 2008-06-30
- Completion
- 2008-10-31
Countries
- Italy
Study Locations
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