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

Phase 3

Completed

• Conditions: Respiratory Insufficiency
• Interventions: Procedure: Tracheostomy on day 3-5 in early group and 10-12 in late group

• Registration Number: NCT00262431
• Lead Sponsor: University of Turin, Italy

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.

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 Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-12-05
• Study First Submitted QC: 2005-12-05
• Study First Posted: 2005-12-06
• Primary Completion: 2008-06
• Study Completion: 2008-10
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-07
• Last Update Posted: 2012-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early (A)	Tracheostomy on day 3-5 in early group and 10-12 in late group	Patients of the EARLY group (A) will be submitted to tracheostomy on day 3-5 from oro/nasotracheal intubation.
Late (B)	Tracheostomy on day 3-5 in early group and 10-12 in late group	Patients of the LATE group (B) will undergo tracheostomy on day 10-12 from oro/nasotracheal intubation.

Primary Outcome Measures

Name	Time	Method
Increase of "ventilator associated pneumonia-free days"	Follow-up terminates on day 28 from the date of oro/nasotracheal intubation.

Secondary Outcome Measures

Name	Time	Method
Increase of "ventilator-free days"	Follow-up terminates on day 28 from the date of oro/nasotracheal intubation
Reduction of mortality	one year

Trial Locations

Locations (1)

University of Turin, Department of Anesthesia and Intensive Care Medicine; 🇮🇹 Turin, Italy