Oral Care Protocol for Preventing Ventilator- Associated Pneumonia

NCT00604916 | Completed Early Phase 1 DMC

• 1 other identifier: MMH-I-S-402
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pneumonia

Keywords

oral hygiene

Outcome Measures

Primary Outcomes (1)

• the oral hygiene status measured by the oral assessment guide and plague index

  every 3~4days

Secondary Outcomes (1)

• The incidence of VAP defined by the Clinical Pulmonary Infection Score

  a 7 day oral care protocol duration

Study Arms (2)

E

EXPERIMENTAL

received a 7 day standardized oral care protocol

Other: standardized oral care protocol - electronic toothbrush

C

PLACEBO COMPARATOR

received a 7 day mimic protocol

Other: mimic protocol

Interventions

standardized oral care protocol - electronic toothbrush OTHER

a standardized 20-minute oral care protocol using an electronic toothbrush to clean and moisturize oral cavity twice daily.

E

mimic protocol OTHER

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

C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• With pneumonia present

Sponsors & Collaborators

• Mackay Memorial Hospital: lead
• National Taiwan University: collaborator

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• li-yin YAO, BSN

  School of Nursing, National Taiwan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 30, 2008
• Study Start: March 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: January 1, 2008
• Last Updated: January 30, 2008

Record last verified: 2008-01