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| Sponsors and Collaborators: |
Mackay Memorial Hospital National Taiwan University |
|---|---|
| Information provided by: | Mackay Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT00604916 |
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: | Prevention, Randomized, Single Blind (Investigator), Parallel Assignment |
| Official Title: | The Effectiveness of an Oral Care Protocol in Preventing Ventilator- Associated Pneumonia for Intensive Care Unit Patient |
| 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 |
|---|---|
|
E: Experimental
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.
|
|
C: Placebo Comparator
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | School of Nursing, National Taiwan University ( li-yin YAO ) |
| Study ID Numbers: | MMH-I-S-402 |
| Study First Received: | January 7, 2008 |
| Last Updated: | January 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00604916 History of Changes |
| Health Authority: | Taiwan: Institutional Review Board |
|
oral hygiene |
|
Respiratory Tract Infections Respiratory Tract Diseases Lung Diseases |
Pneumonia, Ventilator-Associated Cross Infection Pneumonia |
|
Respiratory Tract Infections Respiratory Tract Diseases Lung Diseases Infection |
Pneumonia, Ventilator-Associated Cross Infection Pneumonia |
