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

NCT ID: NCT02223988

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-07-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

subglottic secretion drainage

Group Type: EXPERIMENTAL

subglottic secretion removal

Intervention Type: PROCEDURE

Interventions

subglottic secretion removal

Intervention Type: PROCEDURE

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Marco Ranieri

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pierpaolo Terragni, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

University of Turin - Department of Anesthesia and Intensive Care Medicine

Turin, , Italy

Countries

Italy

Other Identifiers

CS/202

Identifier Type: -

Identifier Source: org_study_id