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

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

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

Study Overview

• Status: Completed
• Conditions: Respiratory Failure
• Intervention / Treatment: Procedure: subglottic secretion removal

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Turin, Italy, 10126
    • University of Turin - Department of Anesthesia and Intensive Care Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: subglottic secretion drainage	Procedure: subglottic secretion removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of VAP	at 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of mechanical ventilation		30 days
ICU length of stay		30 days
Mortality rate	Mortality at 28-day (all-cause mortality) starting from enrollment (at tracheostomy time)	at 28 days
Ventilator free days after tracheostomy		28 days

Collaborators and Investigators

• Sponsor: University of Turin, Italy
• Investigators: Principal Investigator: Pierpaolo Terragni, MD, Department of Anesthesia and Intensive Care Medicine, University of Turin, Italy

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: August 21, 2014
• First Submitted That Met QC Criteria: August 21, 2014
• First Posted (Estimate): August 22, 2014

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 5, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Patients; ventilation; tracheostomy; mechanical
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Respiratory Insufficiency; Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: CS/202