Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248300
Status:
COMPLETED
Last Update Posted:
2015-11-11
First Post:
2005-11-01
Brief Title:
A Peri-intubation Oral Intervention to Reduce Oral Flora and VAP
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
A Peri-intubation Oral Intervention to Reduce Oral Flora and VAP
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is determine if a single early dose of chlorhexidine applied within 12 hours after endotracheal tube insertion will reduce the bacteria in the oral cavity and the incidence of pneumonia in trauma victims
Detailed Description:
Pneumonia is the leading cause of death from nosocomial infections Intubation and mechanical ventilation greatly increase the risk of ventilator associated pneumonia VAP which is highest in trauma burn neurosurgical and surgical patients Oral bacteria have been shown to be responsible for the development of VAP since the endotracheal tube provides a pathway for direct entry of bacteria from the oropharynx to the respiratory tract Therefore reducing the number of microorganisms in the mouth reduces the pool of organisms available for translocation to and colonization of the lung The Tri-Service Oral Health Survey showed that military recruits had inferior oral health when compared to their civilian cohorts Further oral hygiene is likely to deteriorate in combat situations increasing oral microbial flora Intubation of combat casualties in the future will likely be performed in the field by the EMT-B trained combat medic 91W under adverse conditions Therefore interventions to reduce oral microbial flora with intubation are attractive to reduce the incidence of VAP in combat casualties This study will test the effect of a single peri-intubation oral intervention on oral microbial flora and the development of VAP in traumatic injury Two hundred trauma patients requiring endotracheal intubation will be randomly assigned to either the intervention or control group over an 18-month data collection period Data related to oral microbial flora measured by semi-quantitative oral culture and VAP measured by the clinical pulmonary infection score-CPIS will be obtained on study admission at 24 oral culture data only 48 and 72 hours after intubation The exact Wilcoxon two-sample one-sided test will be used to test for difference between groups CPIS data will be compared using an analysis of covariance model Covariates such as baseline oral culture category trauma-injury and severity score TRISS illness severity APACHE III and frequency and timing of usual oral care will also be included The findings from this study will be the first report of an empirically based peri-intubation oral intervention to reduce VAP and can be easily applied to the care of traumatic injury in both combat and civilian casualties
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MDA-905-03-1-TS02 N03-006 | None | None | None |