Strategies to Prevent Pneumonia (SToP Pneumonia)

Ventilator Associated Pneumonia Clinical Trial

Official title:

Oral Care Intervention in Mechanically Ventilated Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234598
• Other study ID #: VCU1006
• Secondary ID: R01NR007652R01 N
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2005
• Last updated: December 4, 2015
• Start date: March 2002
• Est. completion date: February 2008

Study information

• Verified date: December 2015
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 547
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Procedure:
• Toothbrushing only
Toothbrushing three times per 24 hours without chlorhexidine
• Chlorhexidine only
Chlorhexidine oral rinse twice per 24 hours without toothbrushing
• Toothbrushing and Chlorhexidine
Toothbrushing three times per 24 hours plus chlorhexidine twice per 24 hours.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No