Oral Care Protocol for Preventing Ventilator- Associated Pneumonia

Early Phase 1

Completed

• Conditions: Pneumonia
• Interventions: Other: standardized oral care protocol - electronic toothbrush; Other: mimic protocol

• Registration Number: NCT00604916
• Lead Sponsor: Mackay Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2007-11
• Status Verified: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2008-01-07
• Study First Submitted QC: 2008-01-16
• Last Update Submitted: 2008-01-16
• Study First Posted: 2008-01-30
• Last Update Posted: 2008-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

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

Exclusion Criteria

• With pneumonia present

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E	standardized oral care protocol - electronic toothbrush	received a 7 day standardized oral care protocol
C	mimic protocol	received a 7 day mimic protocol

Primary Outcome Measures

Name	Time	Method
the oral hygiene status measured by the oral assessment guide and plague index	every 3~4days

Secondary Outcome Measures

Name	Time	Method
The incidence of VAP defined by the Clinical Pulmonary Infection Score	a 7 day oral care protocol duration