Oral Care Protocol for Preventing Ventilator- Associated Pneumonia

Pneumonia Clinical Trial

— VAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00604916
• Other study ID #: MMH-I-S-402
• Status: Completed
• Phase: Phase 0
• First received: January 7, 2008
• Last updated: January 16, 2008
• Start date: March 2007
• Est. completion date: January 2008

Study information

• Verified date: January 2008
• Source: Mackay Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: January 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• With pneumonia present

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated

Intervention

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.
• mimic protocol
a mimic 20-minute protocol involving moisturizing and attention control was performed for the same intervals.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mackay Memorial Hospital	National Taiwan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the oral hygiene status measured by the oral assessment guide and plague index		every 3~4days	Yes
Secondary	The incidence of VAP defined by the Clinical Pulmonary Infection Score		a 7 day oral care protocol duration	Yes