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

NCT00262431 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2012-06-08

No results posted yet for this study

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.

Conditions

  • Respiratory Insufficiency

Interventions

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.

Sponsors & Collaborators

  • Regione Piemonte

    collaborator OTHER
  • University of Turin, Italy

    lead OTHER

Principal Investigators

  • V. M. Ranieri, MD · University of Turin, Italy

  • V. M. Ranieri, MD · University of Turin, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2008-06-30
Completion
2008-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00262431 on ClinicalTrials.gov