Strategies to Prevent Pneumonia (SToP Pneumonia)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Ventilator Associated Pneumonia	Procedure: Toothbrushing only; Procedure: Chlorhexidine only; Procedure: Toothbrushing and Chlorhexidine	Phase 2

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	547 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	Double (Care Provider, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Oral Care Intervention in Mechanically Ventilated Adults
Study Start Date :	March 2002
Actual Primary Completion Date :	February 2008
Actual Study Completion Date :	February 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT00234598 History of Changes
Other Study ID Numbers:	VCU1006; R01NR007652 ( U.S. NIH Grant/Contract ); R01 NR07652 (NIH)
First Posted:	October 7, 2005
Last Update Posted:	December 8, 2015
Last Verified:	December 2015

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