Respiratory Insufficiency
Conditions
Keywords
Tracheostomy, Tracheostomy timing, Ventilator associated pneumonia, Mechanical ventilation
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 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.
Interventions
PROCEDURETracheostomy 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
Regione Piemonte
University of Turin, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 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: * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase of ventilator associated pneumonia-free days | Follow-up terminates on day 28 from the date of oro/nasotracheal intubation. |
Secondary
| Measure | Time frame |
|---|---|
| Increase of ventilator-free days | Follow-up terminates on day 28 from the date of oro/nasotracheal intubation |
| Reduction of mortality | one year |
Countries
Italy
Outcome results
None listed