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

NCT02223988 | Completed

• 1 other identifier: CS/202
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Respiratory Failure

Keywords

Patients; mechanical; ventilation; tracheostomy

Outcome Measures

Primary Outcomes (1)

• Incidence of VAP

  at 28 days

Secondary Outcomes (4)

• Mortality rate

  at 28 days

• Duration of mechanical ventilation

  30 days

• ICU length of stay

  30 days

• Ventilator free days after tracheostomy

  28 days

Study Arms (1)

subglottic secretion drainage

EXPERIMENTAL

Procedure: subglottic secretion removal

Interventions

subglottic secretion removal PROCEDURE

subglottic secretion drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

University of Turin - Department of Anesthesia and Intensive Care Medicine

Turin, 10126, Italy

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pierpaolo Terragni, MD

  Department of Anesthesia and Intensive Care Medicine, University of Turin, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 22, 2014
• Study Start: July 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

IT (1)