A Peri-intubation Oral Intervention to Reduce Oral Flora and VAP

Pneumonia Clinical Trial

Official title:

A Peri-intubation Oral Intervention to Reduce Oral Flora and VAP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00248300
• Other study ID #: SToPP-IT
• Secondary ID: MDA-905-03-1-TS0
• Status: Completed
• Phase: Phase 4
• First received: November 1, 2005
• Last updated: November 9, 2015
• Start date: August 2005
• Est. completion date: August 2008

Study information

• Verified date: November 2015
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• trauma victim

• endotracheal intubation within the past 12 hours

• mechanical ventilation

Exclusion Criteria:

• diagnosis of pneumonia at the time of intubation

• previous endotracheal tube placement in the last 48 hours

• burn injuries

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia

Intervention

Other:
• Chlorhexidine
Chlorhexidine, 5 ml swab to the oral cavity within 12 hours of endotracheal tube intubation

Locations

Country	Name	City	State
United States	Virginia Commonwealth University School of Nursing	Richmond	Virginia

Sponsors (4)

Lead Sponsor	Collaborator
Virginia Commonwealth University	TriService Nursing Research Program, Uniformed Services University of the Health Sciences, United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (1)

Grap MJ, Munro CL, Elswick RK Jr, Sessler CN, Ward KR. Duration of action of a single, early oral application of chlorhexidine on oral microbial flora in mechanically ventilated patients: a pilot study. Heart Lung. 2004 Mar-Apr;33(2):83-91. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral microbial flora -- measured by semi-quantitative oral culture		At 24, 48 and 72 hours after intubation	No
Secondary	Incidence of ventilator associated pneumonia, measured by the clinical pulmonary infection score (CPIS) and obtained on study admission, 48 and 72 hours after intubation		At 48 and 72 hours after intubation.	No