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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00475579
Recruitment Status : Completed
First Posted : May 21, 2007
Last Update Posted : May 21, 2007
Information provided by:
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

Condition or disease Intervention/treatment Phase
Mechanical Ventilation Procedure: tube with subglottic drainage and polyurethane cuff Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Influence of an Endotracheal Tube With Polyurethane Cuff and Subglottic Secretion Drainage on Ventilator-Associated Pneumonia
Study Start Date : March 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Primary Outcome Measures :
  1. Ventilator-associated pneumonia [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. Late-onset ventilator-associated pneumonia [ Time Frame: 8 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00475579

Sponsors and Collaborators
Hospital Universitario de Canarias
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Principal Investigator: Leonardo Lorente, MD, PhD Intensive care unit

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00475579    
Other Study ID Numbers: 01/03/2006
First Posted: May 21, 2007    Key Record Dates
Last Update Posted: May 21, 2007
Last Verified: May 2007
Keywords provided by Hospital Universitario de Canarias:
ventilator-associated pneumonia
endotracheal tube
polyurethane cuff
polyvinyl cuff
subglottic secretion drainage
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Cross Infection
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections