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Completed

NCT Number: NCT02223988

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

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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Key information

Conditions

Respiratory Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Turin - Department of Anesthesia and Intensive Care Medicine

Turin, 10126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

subglottic secretion removal

Procedure

Primary outcomes

  1. Incidence of VAP

    Time frame: at 28 days

Secondary outcomes

  1. Mortality rate

    Time frame: at 28 days

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

  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

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

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

Acronym: VICTOR

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 22, 2014
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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