Endotracheal Tube With Polyurethane Cuff and Subglottic Secretion Drainage (A/N)

Hospital Universitario de Canarias

Status and phase: Completed; Phase 4

Conditions: Mechanical Ventilation

Treatments: Procedure: tube with subglottic drainage and polyurethane cuff

Study type: Interventional

Funder types: Other

Identifiers

NCT00475579

01/03/2006

Details and patient eligibility

About

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

Full 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.

Enrollment: 280 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)