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CompletedNCT02223988VICTORUpdated May 9, 2017

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

An interventional study of subglottic secretion removal in Respiratory Failure, sponsored by University of Turin, Italy. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-09.

Sponsored by University of Turin, Italy · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

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Conditions studied

  • Respiratory Failure

Keywords

  • Patients
  • mechanical
  • ventilation
  • tracheostomy
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 100 is close to the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

University of Turin, Italy is the lead sponsor of 206 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    subglottic secretion drainage

    Procedure: subglottic secretion removal

Interventions

  • Proceduresubglottic secretion removal
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What researchers measure

Primary outcomes

  1. Incidence of VAP

    Time frame: at 28 days

Secondary outcomes

  1. Mortality rate

    Mortality at 28-day (all-cause mortality) starting from enrollment (at tracheostomy time)

    Time frame: at 28 days

  2. Duration of mechanical ventilation

    Time frame: 30 days

  3. ICU length of stay

    Time frame: 30 days

  4. Ventilator free days after tracheostomy

    Time frame: 28 days

07

Study locations

1 site
  • University of Turin - Department of Anesthesia and Intensive Care Medicine
    Turin, 10126, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02223988
Lead sponsor
University of Turin, Italy
Responsible party
Marco Ranieri (MD, University of Turin, Italy) — Principal investigator
First posted
Aug 22, 2014
Start date
Jul 2014
Primary completion
Jun 2016
Completion
Jul 2016
Last update
May 9, 2017

Study contacts

Pierpaolo Terragni, MD
principal investigator · Department of Anesthesia and Intensive Care Medicine, University of Turin, Italy
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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