Status:
COMPLETED
Efficacy of Early Tracheostomy to Reduce Incidence of Ventilator Acquired Pneumonia (VAP)
Lead Sponsor:
University of Turin, Italy
Collaborating Sponsors:
Regione Piemonte
Conditions:
Respiratory Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 trac...
Eligibility Criteria
Inclusion
- Oro/nasotracheal intubation for less than three days
- Simplified Acute Physiology Score (SAPS II) between 35 and 65 upon admission to Intensive Care Unit (ICU)
Exclusion
- Oro/nasotracheal intubation \> three days
- Age \< 18 years
- Previous otolaryngologic or maxillofacial procedures
- Brain injury patients with intracranial pressure \> 20 mmHg without pharmacological treatment (or intracranial pressure \> 15 mmHg under specific pharmacological treatment) and with cerebral perfusion pressure \< 60 mmHg
- Pregnancy
- Ventilator associated pneumonia, hospital acquired pneumonia, community acquired pneumonia diagnosis before randomization
- Infection in the tracheostomic area
- Acute worsening of chronic obstructive pulmonary disease (COPD)
- Pre-existing malignancies in the tracheostomic area
- Immunosuppressed and/or immunodepressed patients:
- leukocytes \< 1000/microliters
- neutrophils \< 500/microliters
- AIDS
- long-term steroid treatment (daily dose \> 0.5 mg/kg for more than 30 days)
- Patients already enrolled in other trials
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT00262431
Start Date
June 1 2004
End Date
October 1 2008
Last Update
June 8 2012
Active Locations (1)
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1
University of Turin, Department of Anesthesia and Intensive Care Medicine
Turin, Italy, 10126