Endotracheal Tube With Polyurethane Cuff and Subglottic Secretion Drainage

Phase 4

Completed

• Conditions: Mechanical Ventilation

• Registration Number: NCT00475579
• Lead Sponsor: Hospital Universitario de Canarias

Brief Summary

Patients mechanically ventilated using an endotracheal tube with a subglottic secretion drainage lumen and a polyurethane cuff may develop lower ventilator-associated pneumonia than using a conventional endotracheal tube

Detailed Description

Subglottic secretions accumulated above the endotracheal cuff may progress, descending along the channels within folds of the cuff wall, to the lower respiratory tract causing VAP. Subglottic secretion drainage (SSD) appears to be effective in preventing VAP, primarily by reducing early-onset pneumonia; but it may not prevent late-onset pneumonia. We set out the hypothesis that using an endotracheal tube incorporating, besides of a subglottic secretion drainage lumen, a polyurethane cuff (which reduces channel formation and fluids leakage from the subglottic area) it should be also possible to reduce the incidence of late-onset VAP.

Study Timeline

• Study Start: 2006-03
• Study Completion: 2006-10
• Status Verified: 2007-05
• Study First Submitted: 2007-05-17
• Study First Submitted QC: 2007-05-17
• Last Update Submitted: 2007-05-17
• Study First Posted: 2007-05-21
• Last Update Posted: 2007-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• Patients expected to require mechanical ventilation for more than 24 hours

Exclusion Criteria

• Age <18 years,
• Pregnancy,
• HIV,
• Blood leukocytes counts <1000 cells/mm3,
• Solid or haematological tumour,
• Immunosuppressive therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ventilator-associated pneumonia	8 months

Secondary Outcome Measures

Name	Time	Method
Late-onset ventilator-associated pneumonia	8 months