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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00604916
First Posted: January 30, 2008
Last Update Posted: January 30, 2008
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.
Collaborator:
National Taiwan University
Information provided by:
Mackay Memorial Hospital
  Purpose

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 Intervention Phase
Pneumonia Other: standardized oral care protocol - electronic toothbrush Other: mimic protocol Early Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mackay Memorial Hospital:

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

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

Enrollment: 53
Study Start Date: March 2007
Study Completion Date: January 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

  • With pneumonia present
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00604916


Sponsors and Collaborators
Mackay Memorial Hospital
National Taiwan University
Investigators
Principal Investigator: li-yin YAO, BSN School of Nursing, National Taiwan University
  More Information

Responsible Party: li-yin YAO, School of Nursing, National Taiwan University
ClinicalTrials.gov Identifier: NCT00604916     History of Changes
Other Study ID Numbers: MMH-I-S-402
First Submitted: January 7, 2008
First Posted: January 30, 2008
Last Update Posted: January 30, 2008
Last Verified: January 2008

Keywords provided by Mackay Memorial Hospital:
oral hygiene

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
Cytarabine
Methotrexate
Etoposide
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Dermatologic Agents
Folic Acid Antagonists