Occurrence of Ventilator Associated Pneumonia in Italian ICU Using Cuffed Tracheostomy Tubes With Subglottic Secretion Drainage

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02223988
• Date of registration: 21/08/2014
• Prospective Registration: No
• Primary sponsor: University of Turin, Italy
• Public title: Occurrence of Ventilator Associated Pneumonia in Italian ICU Using Cuffed Tracheostomy Tubes With Subglottic Secretion Drainage VICTOR
• Scientific title: Occurrence of Ventilator Associated Pneumonia (VAP) in Italian ICU Using Cuffed Tracheostomy Tubes With Subglottic Secretion Drainage: a Prospective Observational Study.
• Date of first enrolment: July 2014
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02223988
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Italy

Contacts

• Name: Pierpaolo Terragni, MD
• Affiliation: Department of Anesthesia and Intensive Care Medicine, University of Turin, Italy

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Respiratory Failure

Intervention(s)

Procedure: subglottic secretion removal

Primary Outcome(s)

Incidence of VAP [Time Frame: at 28 days]

Secondary Outcome(s)

ICU length of stay [Time Frame: 30 days]

Duration of mechanical ventilation [Time Frame: 30 days]

Mortality rate [Time Frame: at 28 days]

Ventilator free days after tracheostomy [Time Frame: 28 days]

Secondary ID(s)

CS/202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors