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

Primary Purpose

Mechanical Ventilation

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
tube with subglottic drainage and polyurethane cuff
Sponsored by
Hospital Universitario de Canarias
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mechanical Ventilation focused on measuring ventilator-associated pneumonia, endotracheal tube, polyurethane cuff, polyvinyl cuff, subglottic secretion drainage

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Ventilator-associated pneumonia

    Secondary Outcome Measures

    Late-onset ventilator-associated pneumonia

    Full Information

    First Posted
    May 17, 2007
    Last Updated
    May 17, 2007
    Sponsor
    Hospital Universitario de Canarias
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00475579
    Brief Title
    Endotracheal Tube With Polyurethane Cuff and Subglottic Secretion Drainage
    Acronym
    A/N
    Official Title
    Influence of an Endotracheal Tube With Polyurethane Cuff and Subglottic Secretion Drainage on Ventilator-Associated Pneumonia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Hospital Universitario de Canarias

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mechanical Ventilation
    Keywords
    ventilator-associated pneumonia, endotracheal tube, polyurethane cuff, polyvinyl cuff, subglottic secretion drainage

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    280 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    tube with subglottic drainage and polyurethane cuff
    Primary Outcome Measure Information:
    Title
    Ventilator-associated pneumonia
    Time Frame
    8 months
    Secondary Outcome Measure Information:
    Title
    Late-onset ventilator-associated pneumonia
    Time Frame
    8 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Leonardo Lorente, MD, PhD
    Organizational Affiliation
    Intensive care unit
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17872488
    Citation
    Lorente L, Lecuona M, Jimenez 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. doi: 10.1164/rccm.200705-761OC. Epub 2007 Sep 13.
    Results Reference
    derived

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    Endotracheal Tube With Polyurethane Cuff and Subglottic Secretion Drainage

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