Strategies to Prevent Pneumonia (SToP Pneumonia)

Phase 2

Completed

• Conditions: Ventilator Associated Pneumonia
• Interventions: Procedure: Chlorhexidine only; Procedure: Toothbrushing only; Procedure: Toothbrushing and Chlorhexidine

• Registration Number: NCT00234598
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

This study tests whether special oral care provided by nurses to critically ill patients who are on a breathing machine (mechanical ventilator) can help to reduce the build-up of dental plaque on the teeth and reduce the risk of pneumonia.

Detailed Description

Pneumonia is the leading cause of death from hospital-acquired infections. Intubation and mechanical ventilation greatly increase the risk of bacterial ventilator associated pneumonia. Growth of potentially pathogenic bacteria in dental plaque of critically ill patients provides a nidus of infection for microorganisms that have been shown to be responsible for the development of Ventilator Associated Pneumonia. Since these organisms are concentrated in dental plaque, removal of organisms from the oral cavity by oral care interventions is a theoretically attractive method to reduce the risk of development of Ventilator Associated Pneumonia. However, evidence-based protocols for oral care of mechanically ventilated patients are not available. Results of the study have the potential to improve nursing care, and to positively affect patient well-being, morbidity, mortality, and health care costs.

Study Timeline

• Study Start: 2002-03
• Study First Submitted: 2005-10-05
• Study First Submitted QC: 2005-10-05
• Study First Posted: 2005-10-07
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-04
• Last Update Posted: 2015-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 547

Inclusion Criteria

• 18 years or older, admitted to one of four intensive care units at the study hospital, breathing tube in place, and on a breathing machine (mechanical ventilator)

Exclusion Criteria

• Breathing tube in place for more than 24 hours prior to entry into the study, absence of teeth, or a medical diagnosis of pneumonia when the breathing tube is put in.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Chlorhexidine only	Chlorhexidine only	Oral application of chlorhexidine 0.12% oral solution twice per 24 hours (BID) without tooth brushing.
Tooth brushing only	Toothbrushing only	Tooth brushing by study personnel three times per 24 hours (TID) without chlorhexidine application.
Toothbrushing and chlorhexidine	Toothbrushing and Chlorhexidine	Tooth brushing by study personnel three times per 24 hours (TID) and oral application of chlorhexidine 0.12% oral solution twice per 24 hours (BID)

Primary Outcome Measures

Name	Time	Method
Reduction of build-up of dental plaque on the teeth and reduced risk of pneumonia in critical care patients, as a result of special oral care provided by nurses.	7 days

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States