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

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ClinicalTrials.gov Identifier: NCT00262431
Recruitment Status : Completed
First Posted : December 6, 2005
Last Update Posted : June 8, 2012
Sponsor:
Collaborator:
Regione Piemonte
Information provided by (Responsible Party):
Marco Ranieri, University of Turin, Italy

Study Description
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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.

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

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2004
Actual Primary Completion Date : June 2008
Actual Study Completion Date : October 2008

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Increase of "ventilator associated pneumonia-free days" [ Time Frame: Follow-up terminates on day 28 from the date of oro/nasotracheal intubation. ]

Secondary Outcome Measures :
  1. Increase of "ventilator-free days" [ Time Frame: Follow-up terminates on day 28 from the date of oro/nasotracheal intubation ]
  2. Reduction of mortality [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00262431


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

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

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Responsible Party: Marco Ranieri, MD, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT00262431    
Other Study ID Numbers: 1431/28.3
First Posted: December 6, 2005    Key Record Dates
Last Update Posted: June 8, 2012
Last Verified: June 2012
Keywords provided by Marco Ranieri, University of Turin, Italy:
Tracheostomy
Tracheostomy timing
Ventilator associated pneumonia
Mechanical ventilation
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiratory Tract Diseases
Respiration Disorders
 Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases