Strategies to Prevent Pneumonia (SToP Pneumonia)

This study has been completed.
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Virginia Commonwealth University Identifier:
First received: October 5, 2005
Last updated: February 21, 2012
Last verified: April 2010
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.

Condition Intervention Phase
Ventilator Associated Pneumonia
Other: Control
Procedure: Toothbrushing only
Procedure: Chlorhexidine only
Procedure: Toothbrushing and Chlorhexidine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Oral Care Intervention in Mechanically Ventilated Adults

Resource links provided by NLM:

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 547
Study Start Date: March 2002
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1 Other: Control
No toothbrushing and no chlorhexidine
Active Comparator: 2 Procedure: Toothbrushing only
Toothbrushing three times per 24 hours without chlorhexidine
Active Comparator: 3 Procedure: Chlorhexidine only
Chlorhexidine oral rinse twice per 24 hours without toothbrushing
Active Comparator: 4 Procedure: Toothbrushing and Chlorhexidine
Toothbrushing three times per 24 hours plus chlorhexidine twice per 24 hours.

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00234598

United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
Sponsors and Collaborators
Virginia Commonwealth University
National Institute of Nursing Research (NINR)
Principal Investigator: Cindy Munro, RN, ANP,PhD Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University Identifier: NCT00234598     History of Changes
Other Study ID Numbers: VCU1006, R01NR007652, R01 NR07652 (NIH)
Study First Received: October 5, 2005
Last Updated: February 21, 2012
Health Authority: United States: Federal Government

Keywords provided by Virginia Commonwealth University:
Dental Health
Critical Care

Additional relevant MeSH terms:
Pneumonia, Ventilator-Associated
Cross Infection
Lung Diseases
Lung Injury
Respiratory Tract Diseases
Respiratory Tract Infections
Ventilator-Induced Lung Injury
Chlorhexidine gluconate
Anti-Infective Agents
Anti-Infective Agents, Local
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on November 27, 2015