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: December 4, 2015

Last verified: December 2015

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	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:

MedlinePlus related topics: Critical Care Pneumonia

Drug Information available for: Chlorhexidine Chlorhexidine acetate Chlorhexidine hydrochloride Chlorhexidine gluconate Hibiclens

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: Control group, usual care Usual care with no study interventions provided; no tooth brushing intervention and no chlorhexidine intervention. Usual care
Active Comparator: Tooth brushing only Tooth brushing by study personnel three times per 24 hours (TID) without chlorhexidine application.	Procedure: Toothbrushing only Toothbrushing three times per 24 hours without chlorhexidine
Active Comparator: Chlorhexidine only Oral application of chlorhexidine 0.12% oral solution twice per 24 hours (BID) without tooth brushing.	Procedure: Chlorhexidine only Chlorhexidine oral rinse twice per 24 hours without toothbrushing
Active Comparator: 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)	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 (Adult, Senior)
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

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 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


Responsible Party:	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT00234598 History of Changes
Other Study ID Numbers:	VCU1006 R01NR007652
Study First Received:	October 5, 2005
Last Updated:	December 4, 2015
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 Disinfectants Dermatologic Agents

ClinicalTrials.gov processed this record on September 30, 2016

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