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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00262431
First Posted: December 6, 2005
Last Update Posted: June 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Regione Piemonte
Information provided by (Responsible Party):
Marco Ranieri, University of Turin, Italy
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Marco Ranieri, 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. ]

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

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

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
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, Italy
Study Director: V. M. Ranieri, MD University of Turin, Italy
  More Information

Additional Information:
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
First Submitted: December 5, 2005
First Posted: December 6, 2005
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:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases