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

The study aims to assess early (one to three days after intubation) tracheostomy effectiveness in terms of reduction in ventilator associated pneumonia (VAP) incidence.

Study Overview

• Status: Completed
• Conditions: Respiratory Insufficiency
• Intervention / Treatment: Procedure: Tracheostomy on day 3-5 in early group and 10-12 in late group

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 Type: Interventional
• Enrollment (Actual): 320
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Turin, Italy, 10126
    • University of Turin, Department of Anesthesia and Intensive Care Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Turin, Italy
• Collaborators: Regione Piemonte
• Investigators: Study Director: V. M. Ranieri, MD, University of Turin, Italy; Principal Investigator: V. M. Ranieri, MD, University of Turin, Italy

Publications and helpful links

General Publications

• Terragni PP, Antonelli M, Fumagalli R, Faggiano C, Berardino M, Pallavicini FB, Miletto A, Mangione S, Sinardi AU, Pastorelli M, Vivaldi N, Pasetto A, Della Rocca G, Urbino R, Filippini C, Pagano E, Evangelista A, Ciccone G, Mascia L, Ranieri VM. Early vs late tracheotomy for prevention of pneumonia in mechanically ventilated adult ICU patients: a randomized controlled trial. JAMA. 2010 Apr 21;303(15):1483-9. doi: 10.1001/jama.2010.447.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: December 5, 2005
• First Submitted That Met QC Criteria: December 5, 2005
• First Posted (Estimate): December 6, 2005

Study Record Updates

• Last Update Posted (Estimate): June 8, 2012
• Last Update Submitted That Met QC Criteria: June 7, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Tracheostomy; Mechanical ventilation; Ventilator associated pneumonia; Tracheostomy timing
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 1431/28.3