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

Study Overview
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Brief Summary
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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
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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
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Respiratory Insufficiency

Intervention / Treatment
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* Procedure: Tracheostomy on day 3-5 in early group and 10-12 in late group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early (A)<br>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<br>* 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.<br>|
| Active Comparator: Late (B)<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tracheostomy, Tracheostomy timing, Ventilator associated pneumonia, Mechanical ventilation