Strategies to Prevent Pneumonia (SToP Pneumonia)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00234598
First received: October 5, 2005
Last updated: February 21, 2012
Last verified: April 2010

October 5, 2005
February 21, 2012
March 2002
February 2008   (final data collection date for primary outcome measure)
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. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00234598 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Strategies to Prevent Pneumonia (SToP Pneumonia)
Oral Care Intervention in Mechanically Ventilated Adults

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Ventilator Associated Pneumonia
  • Other: Control
    No toothbrushing and no chlorhexidine
  • Procedure: Toothbrushing only
    Toothbrushing three times per 24 hours without chlorhexidine
  • Procedure: Chlorhexidine only
    Chlorhexidine oral rinse twice per 24 hours without toothbrushing
  • Procedure: Toothbrushing and Chlorhexidine
    Toothbrushing three times per 24 hours plus chlorhexidine twice per 24 hours.
  • No Intervention: 1
    Intervention: Other: Control
  • Active Comparator: 2
    Intervention: Procedure: Toothbrushing only
  • Active Comparator: 3
    Intervention: Procedure: Chlorhexidine only
  • Active Comparator: 4
    Intervention: Procedure: Toothbrushing and Chlorhexidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
547
February 2008
February 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00234598
VCU1006, R01NR007652, R01 NR07652 (NIH)
No
Virginia Commonwealth University
Virginia Commonwealth University
National Institute of Nursing Research (NINR)
Principal Investigator: Cindy Munro, RN, ANP,PhD Virginia Commonwealth University
Virginia Commonwealth University
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP