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

NCT ID: NCT00262431

Last Updated: 2012-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2008-10-31

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.

Conditions

Respiratory Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early (A)

Patients of the EARLY group (A) will be submitted to tracheostomy on day 3-5 from oro/nasotracheal intubation.

Group Type: ACTIVE_COMPARATOR

Tracheostomy on day 3-5 in early group and 10-12 in late group

Intervention Type: PROCEDURE

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)

Patients of the LATE group (B) will undergo tracheostomy on day 10-12 from oro/nasotracheal intubation.

Group Type: ACTIVE_COMPARATOR

Tracheostomy on day 3-5 in early group and 10-12 in late group

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regione Piemonte

OTHER

Sponsor Role: collaborator

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Marco Ranieri

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

V. M. Ranieri, MD

Role: PRINCIPAL_INVESTIGATOR

University of Turin, Italy

V. M. Ranieri, MD

Role: STUDY_DIRECTOR

University of Turin, Italy

Locations

University of Turin, Department of Anesthesia and Intensive Care Medicine

Turin, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 20407057 (View on PubMed)

Other Identifiers

1431/28.3

Identifier Type: -

Identifier Source: org_study_id