Back to resultsOccurrence of Ventilator Associated Pneumonia in Italian ICU Using Cuffed Tracheostomy Tubes With Subglottic Secretion Drainage (VICTOR)
Primary Purpose
Respiratory Failure
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
subglottic secretion removal
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Failure focused on measuring Patients, mechanical, ventilation, tracheostomy
Eligibility 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
Sites / Locations
- University of Turin - Department of Anesthesia and Intensive Care Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
subglottic secretion drainage
Arm Description
Outcomes
Primary Outcome Measures
Incidence of VAP
Secondary Outcome Measures
Mortality rate
Mortality at 28-day (all-cause mortality) starting from enrollment (at tracheostomy time)
Duration of mechanical ventilation
ICU length of stay
Ventilator free days after tracheostomy
Full Information
NCT ID
NCT02223988
First Posted
August 21, 2014
Last Updated
May 5, 2017
Sponsor
University of Turin, Italy
1. Study Identification
Unique Protocol Identification Number
NCT02223988
Brief Title
Occurrence of Ventilator Associated Pneumonia in Italian ICU Using Cuffed Tracheostomy Tubes With Subglottic Secretion Drainage
Acronym
VICTOR
Official Title
Occurrence of Ventilator Associated Pneumonia (VAP) in Italian ICU Using Cuffed Tracheostomy Tubes With Subglottic Secretion Drainage: a Prospective Observational Study.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy
4. Oversight
5. Study Description
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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
Patients, mechanical, ventilation, tracheostomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
subglottic secretion drainage
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
subglottic secretion removal
Primary Outcome Measure Information:
Title
Incidence of VAP
Time Frame
at 28 days
Secondary Outcome Measure Information:
Title
Mortality rate
Description
Mortality at 28-day (all-cause mortality) starting from enrollment (at tracheostomy time)
Time Frame
at 28 days
Title
Duration of mechanical ventilation
Time Frame
30 days
Title
ICU length of stay
Time Frame
30 days
Title
Ventilator free days after tracheostomy
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierpaolo Terragni, MD
Organizational Affiliation
Department of Anesthesia and Intensive Care Medicine, University of Turin, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Turin - Department of Anesthesia and Intensive Care Medicine
City
Turin
ZIP/Postal Code
10126
Country
Italy
12. IPD Sharing Statement
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Occurrence of Ventilator Associated Pneumonia in Italian ICU Using Cuffed Tracheostomy Tubes With Subglottic Secretion Drainage
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