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Oral Care Protocol for Preventing Ventilator- Associated Pneumonia

NCT ID: NCT00604916

Last Updated: 2008-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pneumonia

Keywords

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oral hygiene

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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E

received a 7 day standardized oral care protocol

Group Type EXPERIMENTAL

standardized oral care protocol - electronic toothbrush

Intervention Type OTHER

a standardized 20-minute oral care protocol using an electronic toothbrush to clean and moisturize oral cavity twice daily.

C

received a 7 day mimic protocol

Group Type PLACEBO_COMPARATOR

mimic protocol

Intervention Type OTHER

a mimic 20-minute protocol involving moisturizing and attention control was performed for the same intervals.

Interventions

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standardized oral care protocol - electronic toothbrush

a standardized 20-minute oral care protocol using an electronic toothbrush to clean and moisturize oral cavity twice daily.

Intervention Type OTHER

mimic protocol

a mimic 20-minute protocol involving moisturizing and attention control was performed for the same intervals.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* With pneumonia present
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University

OTHER

Sponsor Role collaborator

Mackay Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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School of Nursing, National Taiwan University

Principal Investigators

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li-yin YAO, BSN

Role: PRINCIPAL_INVESTIGATOR

School of Nursing, National Taiwan University

Other Identifiers

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MMH-I-S-402

Identifier Type: -

Identifier Source: org_study_id