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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
History of Changes
  Purpose

The study aims to assess early (one to three days after intubation) tracheostomy effectiveness in terms of reduction in ventilator associated pneumonia (VAP) incidence.


Condition Intervention Phase
Respiratory Insufficiency
 Procedure: Tracheostomy on day 3-5 in early group and 10-12 in late group
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 320
Study Start Date: June 2004
Study Completion Date: October 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Early (A)
Patients of the EARLY group (A) will be submitted to tracheostomy on day 3-5 from oro/nasotracheal intubation.
 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: Late (B)
Patients of the LATE group (B) will undergo tracheostomy on day 10-12 from oro/nasotracheal intubation.
 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262431

Locations
Italy
University of Turin, Department of Anesthesia and Intensive Care Medicine
Turin, Italy, 10126
Sponsors and Collaborators
University of Turin, Italy
Regione Piemonte
Investigators
Principal Investigator: V. M. Ranieri, MD University of Turin
Study Director: V. M. Ranieri, MD University of Turin
  More Information

No publications provided by University of Turin, Italy

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Marco Ranieri, MD, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT00262431     History of Changes
Other Study ID Numbers: 1431/28.3
Study First Received: December 5, 2005
Last Updated: June 7, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by University of Turin, Italy:
Tracheostomy
Tracheostomy timing
Ventilator associated pneumonia
Mechanical ventilation

Additional relevant MeSH terms:
Respiratory Insufficiency
Pneumonia, Ventilator-Associated
Respiration Disorders
Respiratory Tract Diseases
Cross Infection
Infection
 Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Pneumonia
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 16, 2013