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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00604916
Recruitment Status : Completed
First Posted : January 30, 2008
Last Update Posted : January 30, 2008
National Taiwan University
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Pneumonia Other: standardized oral care protocol - electronic toothbrush Other: mimic protocol Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: The Effectiveness of an Oral Care Protocol in Preventing Ventilator- Associated Pneumonia for Intensive Care Unit Patient
Study Start Date : March 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : January 2008

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.

Primary Outcome Measures :
  1. the oral hygiene status measured by the oral assessment guide and plague index [ Time Frame: every 3~4days ]

Secondary Outcome Measures :
  1. The incidence of VAP defined by the Clinical Pulmonary Infection Score [ Time Frame: a 7 day oral care protocol duration ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • With pneumonia present

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00604916

Sponsors and Collaborators
Mackay Memorial Hospital
National Taiwan University
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Principal Investigator: li-yin YAO, BSN School of Nursing, National Taiwan University
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Responsible Party: li-yin YAO, School of Nursing, National Taiwan University Identifier: NCT00604916    
Other Study ID Numbers: MMH-I-S-402
First Posted: January 30, 2008    Key Record Dates
Last Update Posted: January 30, 2008
Last Verified: January 2008
Keywords provided by Mackay Memorial Hospital:
oral hygiene
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection