Status:
COMPLETED
Occurrence of Ventilator Associated Pneumonia in Italian ICU Using Cuffed Tracheostomy Tubes With Subglottic Secretion Drainage
Lead Sponsor:
University of Turin, Italy
Conditions:
Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Ventilator-associated pneumonia (VAP) is a serious complication and carries increased risks of morbidity and mortality for patients who require mechanical ventilation. VAP is associated with the cont...
Eligibility Criteria
Inclusion
- Patients on mechanical ventilation for respiratory failure for at least 72 hours.
- A score of 35 to 65 on the Simplified Acute Physiology Score II (SAPS II).
- Does not have a pulmonary infection estimated by a Clinical Pulmonary Infection Score (CPIS).
- Age \>= 18 years.
- have no exclusion criteria
Exclusion
- A history of esophageal, tracheal or pulmonary cancer or an existing malignancy within the trachea at the tracheostomy site.
- Previous surgery at the tracheostomy site (e.g. thyroidectomy).
- Bleeding diathesis (e.g. due to anticoagulation therapy).
- Emergency surgical airway management.
- Morbid obesity and/or neck edema (skin to trachea distance may render tracheostomy tube too short).
- Pre-existing infection at the tracheostomy site.
- Uncertainty in identifying the anatomical landmarks.
- Patients with a do not resuscitate order.
- Immunosuppressed and/or immunodepressed patients (Immunodepression being defined by the following conditions: 1-Leukocytes \< 1000/µl, 2-Neutrophils \< 500/µl. 3-AIDS Long-term steroid treatment (daily dose \> 0.5 mg/kg) for more than 30 days)
- Patients already enrolled in other trials
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02223988
Start Date
July 1 2014
End Date
July 1 2016
Last Update
May 9 2017
Active Locations (1)
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1
University of Turin - Department of Anesthesia and Intensive Care Medicine
Turin, Italy, 10126