Oral Care Protocol for Preventing Ventilator- Associated... | NCT00604916

Studies
Oral Care Protocol for Preventing Ventilator- Associated Pneumonia

NCT00604916

Sponsor

Mackay Memorial Hospital

Status

Completed

Last Update Posted

Jan 30, 2008Estimated

Enrollment

53Actual

Phase

Early Phase 1

Conditions

Pneumonia

Interventions

standardized oral care protocol - electronic toothbrush
mimic protocol

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Nov 2007Actual

Completion Date

Jan 2008Actual

First Submitted Date

Jan 7, 2008

First Submission Date that Met QC Criteria

Jan 16, 2008

First Posted Date

Jan 30, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2008

Last Update Posted Date

Jan 30, 2008Estimated

Name	Class
National Taiwan University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the oral hygiene status measured by the oral assessment guide and plague index		every 3~4days

Secondary Outcomes

Measure	Description	Time Frame
The incidence of VAP defined by the Clinical Pulmonary Infection Score		a 7 day oral care protocol duration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

With pneumonia present

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
li-yin YAO, BSN	School of Nursing, National Taiwan University	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011014	Pneumonia

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided