Endotracheal Tube With Polyurethane Cuff and Subglottic Secretion Drainage - Full Text View

Sponsored by:	Hospital Universitario de Canarias
Information provided by:	Hospital Universitario de Canarias
ClinicalTrials.gov Identifier:	NCT00475579

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 IV

MedlinePlus related topics: Pneumonia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment
Official Title:	Influence of an Endotracheal Tube With Polyurethane Cuff and Subglottic Secretion Drainage on Ventilator-Associated Pneumonia

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

Publications indexed to this study:

Lorente L, Lecuona M, Jiménez A, Mora ML, Sierra A. Influence of an endotracheal tube with polyurethane cuff and subglottic secretion drainage on pneumonia. Am J Respir Crit Care Med. 2007 Dec 1;176(11):1079-83. Epub 2007 Sep 13.

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

Keywords provided by Hospital Universitario de Canarias:

ventilator-associated pneumonia
endotracheal tube
polyurethane cuff
polyvinyl cuff
subglottic secretion drainage

Study placed in the following topic categories:

Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases

Pneumonia, Ventilator-Associated
Cross Infection
Pneumonia

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on January 16, 2009