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Oral Care Protocol for Preventing Ventilator- Associated Pneumonia (VAP)

Primary Purpose

Pneumonia

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
standardized oral care protocol - electronic toothbrush
mimic protocol
Sponsored by
Mackay Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumonia focused on measuring oral hygiene

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients newly admitted to SICU who were under ventilator support for 48~72 hours

Exclusion Criteria:

  • With pneumonia present

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    E

    C

    Arm Description

    received a 7 day standardized oral care protocol

    received a 7 day mimic protocol

    Outcomes

    Primary Outcome Measures

    the oral hygiene status measured by the oral assessment guide and plague index

    Secondary Outcome Measures

    The incidence of VAP defined by the Clinical Pulmonary Infection Score

    Full Information

    First Posted
    January 7, 2008
    Last Updated
    January 16, 2008
    Sponsor
    Mackay Memorial Hospital
    Collaborators
    National Taiwan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00604916
    Brief Title
    Oral Care Protocol for Preventing Ventilator- Associated Pneumonia
    Acronym
    VAP
    Official Title
    The Effectiveness of an Oral Care Protocol in Preventing Ventilator- Associated Pneumonia for Intensive Care Unit Patient
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2007 (undefined)
    Primary Completion Date
    November 2007 (Actual)
    Study Completion Date
    January 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Mackay Memorial Hospital
    Collaborators
    National Taiwan University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The Nosocomial Pneumonia remains to be a major complication for patients who were incubated with ventilation. Most cases are attributed to increased bacteria flora in oropharyngeal secretion and aspiration of those organisms. Research indicates that the Gram-Negative Bacteria grows in upper air way and trachea rapidly during the initial 2-4 hospital days and the dental plague also increased dramatically at the first 5 days. About 50% cases with prolonged intubation experienced temporal swallowing disorders and majority of them recovered 7 days post weaning. Some evidence exist suggesting that oral care could reduce bacterial flora, prevent aspiration, and subsequently decrease the incidence of ventilation-associated pneumonia for this group of high risk patients. This study aims to evaluate the effectiveness of a standardized oral care protocol in improving oral hygiene and reducing the incidence of pneumonia on a sample of surgical patients at intensive care unit.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pneumonia
    Keywords
    oral hygiene

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    53 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    E
    Arm Type
    Experimental
    Arm Description
    received a 7 day standardized oral care protocol
    Arm Title
    C
    Arm Type
    Placebo Comparator
    Arm Description
    received a 7 day mimic protocol
    Intervention Type
    Other
    Intervention Name(s)
    standardized oral care protocol - electronic toothbrush
    Intervention Description
    a standardized 20-minute oral care protocol using an electronic toothbrush to clean and moisturize oral cavity twice daily.
    Intervention Type
    Other
    Intervention Name(s)
    mimic protocol
    Intervention Description
    a mimic 20-minute protocol involving moisturizing and attention control was performed for the same intervals.
    Primary Outcome Measure Information:
    Title
    the oral hygiene status measured by the oral assessment guide and plague index
    Time Frame
    every 3~4days
    Secondary Outcome Measure Information:
    Title
    The incidence of VAP defined by the Clinical Pulmonary Infection Score
    Time Frame
    a 7 day oral care protocol duration

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients newly admitted to SICU who were under ventilator support for 48~72 hours Exclusion Criteria: With pneumonia present
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    li-yin YAO, BSN
    Organizational Affiliation
    School of Nursing, National Taiwan University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Oral Care Protocol for Preventing Ventilator- Associated Pneumonia

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