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

The Effectiveness of an Oral Care Protocol in Preventing Ventilator- Associated Pneumonia for Intensive Care Unit Patient

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia
• Intervention / Treatment: Other: standardized oral care protocol - electronic toothbrush; Other: mimic protocol

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• With pneumonia present

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E; received a 7 day standardized oral care protocol	Other: 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.
Placebo Comparator: C; received a 7 day mimic protocol	Other: mimic protocol; a mimic 20-minute protocol involving moisturizing and attention control was performed for the same intervals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the oral hygiene status measured by the oral assessment guide and plague index	every 3~4days

Secondary Outcome Measures

Outcome Measure	Time Frame
The incidence of VAP defined by the Clinical Pulmonary Infection Score	a 7 day oral care protocol duration

Collaborators and Investigators

• Sponsor: Mackay Memorial Hospital
• Collaborators: National Taiwan University
• Investigators: Principal Investigator: li-yin YAO, BSN, School of Nursing, National Taiwan University

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: January 7, 2008
• First Submitted That Met QC Criteria: January 16, 2008
• First Posted (Estimate): January 30, 2008

Study Record Updates

• Last Update Posted (Estimate): January 30, 2008
• Last Update Submitted That Met QC Criteria: January 16, 2008
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Keywords: oral hygiene
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: MMH-I-S-402