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

Respiratory Insufficiency Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00262431
• Other study ID #: 1431/28.3
• Status: Completed
• Phase: Phase 3
• First received: December 5, 2005
• Last updated: June 7, 2012
• Start date: June 2004
• Est. completion date: October 2008

Study information

• Verified date: June 2012
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: October 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pneumonia, Ventilator-Associated
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Italy	University of Turin, Department of Anesthesia and Intensive Care Medicine	Turin

Sponsors (2)

Lead Sponsor	Collaborator
University of Turin, Italy	Regione Piemonte

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase of "ventilator associated pneumonia-free days"		Follow-up terminates on day 28 from the date of oro/nasotracheal intubation.	No
Secondary	Increase of "ventilator-free days"		Follow-up terminates on day 28 from the date of oro/nasotracheal intubation	No
Secondary	Reduction of mortality		one year	No

External Links

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