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

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitario de Canarias
ClinicalTrials.gov Identifier:
NCT00475579
First received: May 17, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

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 Intervention Phase
Mechanical Ventilation
 Procedure: tube with subglottic drainage and polyurethane cuff
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Influence of an Endotracheal Tube With Polyurethane Cuff and Subglottic Secretion Drainage on Ventilator-Associated Pneumonia

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Further study details as provided by Hospital Universitario de Canarias:

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

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

Enrollment: 280
Study Start Date: March 2006
Study Completion Date: October 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00475579

Sponsors and Collaborators
Hospital Universitario de Canarias
Investigators
Principal Investigator: Leonardo Lorente, MD, PhD Intensive Care Unit
  More Information

No publications provided by Hospital Universitario de Canarias

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00475579     History of Changes
Other Study ID Numbers: 01/03/2006
Study First Received: May 17, 2007
Last Updated: May 17, 2007
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital Universitario de Canarias:
ventilator-associated pneumonia
endotracheal tube
polyurethane cuff
polyvinyl cuff
subglottic secretion drainage

Additional relevant MeSH terms:
Pneumonia, Ventilator-Associated
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
 Lung Diseases
Respiratory Tract Diseases
Pneumonia
Respiratory Tract Infections

ClinicalTrials.gov processed this record on June 18, 2013