The study aims to assess early (one to three days after intubation) tracheostomy effectiveness in terms of reduction in ventilator associated pneumonia (VAP) incidence.
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.
Inclusion Criteria:
Exclusion Criteria:
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:
Patients already enrolled in other trials