Endotracheal Tube With Polyurethane Cuff and Subglottic Secretion Drainage

Mechanical Ventilation Clinical Trial

— A/N  

Official title:

Influence of an Endotracheal Tube With Polyurethane Cuff and Subglottic Secretion Drainage on Ventilator-Associated Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00475579
• Other study ID #: 01/03/2006
• Status: Completed
• Phase: Phase 4
• First received: May 17, 2007
• Last updated: May 17, 2007
• Start date: March 2006
• Est. completion date: October 2006

Study information

• Verified date: May 2007
• Source: Hospital Universitario de Canarias
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Mechanical Ventilation
• Pneumonia, Ventilator-Associated

Intervention

Procedure:
• tube with subglottic drainage and polyurethane cuff

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario de Canarias

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator-associated pneumonia		8 months
Secondary	Late-onset ventilator-associated pneumonia		8 months