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Strategies to Prevent Pneumonia (SToP Pneumonia)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
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
History of Changes
  Purpose

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:

U.S. FDA Resources

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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234598

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

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov 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:
Pneumonia
Dental Health
Critical Care

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
 Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on May 19, 2013