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

Respiratory Failure Clinical Trial

— VICTOR  

Official title:

Occurrence of Ventilator Associated Pneumonia (VAP) in Italian ICU Using Cuffed Tracheostomy Tubes With Subglottic Secretion Drainage: a Prospective Observational Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02223988
• Other study ID #: CS/202
• Status: Completed
• Phase: N/A
• First received: August 21, 2014
• Last updated: May 5, 2017
• Start date: July 2014
• Est. completion date: July 2016

Study information

• Verified date: May 2017
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 contamination and colonization of bacteria in the lower airway. These bacteria may be present in the lower airway by the aspiration of oropharyngeal secretions. Therefore limiting the amount of secretions that pass the glottis and enter the airway is paramount.

Patients who require prolonged mechanical ventilation may have a tracheostomy tube placed to manage breathing. These tubes may have a distal cuff which sits within the trachea. When the cuff is inflated, oropharyngeal secretions will pool above the cuff of the tracheostomy tube thereby limiting the amount of secretions entering the lower airway. These secretions may leak around the cuff and cause tracheobronchial colonization. It has been shown that removal of secretions that pool above the cuff via dorsal lumen suction leads to a decreased incidence of VAP.

The purpose of this study is to measure the effect of suction above the cuff tracheostomy tubes related to VAP incidence

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Procedure:
• subglottic secretion removal

Locations

Country	Name	City	State
Italy	University of Turin - Department of Anesthesia and Intensive Care Medicine	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of VAP		at 28 days
Secondary	Mortality rate	Mortality at 28-day (all-cause mortality) starting from enrollment (at tracheostomy time)	at 28 days
Secondary	Duration of mechanical ventilation		30 days
Secondary	ICU length of stay		30 days
Secondary	Ventilator free days after tracheostomy		28 days