Efficacy of Early Tracheostomy to Reduce Incidence of Ventilator Acquired Pneumonia (VAP)

This study has been completed.
Sponsor:
Collaborator:
Regione Piemonte
Information provided by (Responsible Party):
Marco Ranieri, University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT00262431
First received: December 5, 2005
Last updated: June 7, 2012
Last verified: June 2012

December 5, 2005
June 7, 2012
June 2004
June 2008   (final data collection date for primary outcome measure)
Increase of "ventilator associated pneumonia-free days" [ Time Frame: Follow-up terminates on day 28 from the date of oro/nasotracheal intubation. ] [ Designated as safety issue: No ]
Increase of "ventilator associated pneumonia-free days"
Complete list of historical versions of study NCT00262431 on ClinicalTrials.gov Archive Site
  • Increase of "ventilator-free days" [ Time Frame: Follow-up terminates on day 28 from the date of oro/nasotracheal intubation ] [ Designated as safety issue: No ]
  • Reduction of mortality [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Increase of "ventilator-free days"
  • Reduction of mortality
Not Provided
Not Provided
 
Efficacy of Early Tracheostomy to Reduce Incidence of Ventilator Acquired Pneumonia (VAP)
Not Provided

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Respiratory Insufficiency
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.
  • Active Comparator: Early (A)
    Patients of the EARLY group (A) will be submitted to tracheostomy on day 3-5 from oro/nasotracheal intubation.
    Intervention: Procedure: Tracheostomy on day 3-5 in early group and 10-12 in late group
  • Active Comparator: Late (B)
    Patients of the LATE group (B) will undergo tracheostomy on day 10-12 from oro/nasotracheal intubation.
    Intervention: Procedure: Tracheostomy on day 3-5 in early group and 10-12 in late group
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
320
October 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00262431
1431/28.3
Not Provided
Marco Ranieri, University of Turin, Italy
University of Turin, Italy
Regione Piemonte
Principal Investigator: V. M. Ranieri, MD University of Turin
Study Director: V. M. Ranieri, MD University of Turin
University of Turin, Italy
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP