Clinical trial NCT00262431: Efficacy of Early Tracheostomy to Reduce Incidence of Ventilator Acquired Pneumonia (VAP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Insufficiency
Keywords: Tracheostomy
Tracheostomy timing
Ventilator associated pneumonia
Mechanical ventilation
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
Collaborators: name: Regione Piemonte
First posted: 2005-12-06
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Increase of "ventilator associated pneumonia-free days"
timeFrame: Follow-up terminates on day 28 from the date of oro/nasotracheal intubation.
Secondary outcomes:
measure: Increase of "ventilator-free days"
timeFrame: Follow-up terminates on day 28 from the date of oro/nasotracheal intubation
measure: Reduction of mortality
timeFrame: one year
Other outcomes:
Locations:
city: Turin
country: Italy
facility: University of Turin, Department of Anesthesia and Intensive Care Medicine
Study officials:
affiliation: University of Turin, Italy
name: V. M. Ranieri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turin, Italy
name: V. M. Ranieri, MD
role: STUDY_DIRECTOR
References:
citation: Terragni PP, Antonelli M, Fumagalli R, Faggiano C, Berardino M, Pallavicini FB, Miletto A, Mangione S, Sinardi AU, Pastorelli M, Vivaldi N, Pasetto A, Della Rocca G, Urbino R, Filippini C, Pagano E, Evangelista A, Ciccone G, Mascia L, Ranieri VM. Early vs late tracheotomy for prevention of pneumonia in mechanically ventilated adult ICU patients: a randomized controlled trial. JAMA. 2010 Apr 21;303(15):1483-9. doi: 10.1001/jama.2010.447.