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

This study has been completed.
Sponsor:
Collaborator:
National Taiwan University
Information provided by:
Mackay Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00604916
First received: January 7, 2008
Last updated: January 16, 2008
Last verified: January 2008
  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
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 7, 2008
Last Updated: January 16, 2008
Health Authority: Taiwan: Institutional Review Board

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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on August 18, 2014