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

University of Turin, Italy320 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

320

Conditions

Respiratory Insufficiency

Interventions

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

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Turin, Department of Anesthesia and Intensive Care Medicine

Turin, Italy

Outcomes

Primary Outcomes

Increase of "ventilator associated pneumonia-free days"

Time frame: Follow-up terminates on day 28 from the date of oro/nasotracheal intubation.

Secondary Outcomes

Increase of "ventilator-free days"

Time frame: Follow-up terminates on day 28 from the date of oro/nasotracheal intubation

Reduction of mortality

Time frame: one year

Data from ClinicalTrials.gov

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