Efficacy of Early Tracheostomy to Reduce Incidence of Ventilator Acquired Pneumonia (VAP) - Full Text View

Sponsors and Collaborators:	University of Turin, Italy Regione Piemonte
Information provided by:	University of Turin, Italy
ClinicalTrials.gov Identifier:	NCT00262431

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 III

MedlinePlus related topics: Pneumonia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

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 ]

Estimated 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
Early (A): Active Comparator 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.
Late (B): Active Comparator 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

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	University of Turin, Italy ( Marco Ranieri )
Study ID Numbers:	1431/28.3
Study First Received:	December 5, 2005
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00262431
Health Authority:	Italy: Ministry of Health

Keywords provided by University of Turin, Italy:

Tracheostomy
Tracheostomy timing
Ventilator associated pneumonia
Mechanical ventilation

Study placed in the following topic categories:

Respiratory Insufficiency
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases

Respiration Disorders
Pneumonia, Ventilator-Associated
Cross Infection
Pneumonia

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on January 16, 2009