Effect of Improved Oral Hygiene to Prevent Pneumonia in Hospitalized Patients - Full Text View

Sponsored by:	National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by:	National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier:	NCT00123123

Purpose

Recent studies have found that poor oral hygiene may foster the colonization of the oropharynx by potential respiratory pathogens in mechanically-ventilated (MV), intensive care unit (ICU) patients. Thus, improvements in oral hygiene in MV-ICU patients may prevent ventilator-associated pneumonia (VAP).

The specific aims of this investigation are: 1) to organize the necessary infrastructure to develop and perform a pilot clinical trial to evaluate alternative oral hygiene procedures to prevent VAP; 2) to use this organization to perform a pilot clinical trial to determine if the use of oral topical chlorhexidine gluconate (CHX) will prevent dental plaque, oropharyngeal colonization by respiratory pathogens, and VAP in MV-ICU patients.

Condition	Intervention	Phase
Pneumonia	Drug: chlorhexidine gluconate oral rinse (0.12%)	Phase II

MedlinePlus related topics: Dental Health Pneumonia

Drug Information available for: Chlorhexidine Chlorhexidine digluconate Hibiclens Gluconic acid D-Gluconic acid, monosodium salt Manganese gluconate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	Oral Health and Ventilator-Associated Pneumonia

Further study details as provided by National Institute of Dental and Craniofacial Research (NIDCR):

Primary Outcome Measures:

Colonization of the oral cavity by target respiratory pathogens (teeth/denture/buccal mucosa) at >1% of the aerobic cultivable flora [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The Clinical Pulmonary Infection Score (CPIS) system will be used to calculate a CPIS score. This system is based on five different elements: [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	March 2005
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Intervention Details:

chlorhexidine gluconate oral rinse

Detailed Description:

Recent studies have found that poor oral hygiene may foster the colonization of the oropharynx by potential respiratory pathogens in mechanically-ventilated (MV), intensive care unit (ICU) patients. Thus, improvements in oral hygiene in MV-ICU patients may prevent ventilator-associated pneumonia (VAP). The Specific Aims of this investigation are: 1) to organize the necessary infrastructure to develop and perform a pilot clinical trial to evaluate alternative oral hygiene procedures to prevent VAP; 2) to use this organization to perform a pilot clinical trial to determine if the use of oral topical chlorhexidine gluconate (CHX) will prevent dental plaque, oropharyngeal colonization by respiratory pathogens, and VAP in MV-ICU patients. This pilot longitudinal, double blind intervention study will consider the appropriate frequency of delivery of CHX to improve oral hygiene in MV-ICU patients. Preliminary data from these pilot studies will also allow accurate sample size calculations to be made for a large-scale multi-center clinical trial; and 3) to perform molecular epidemiological studies to identify and genetically type bacteria cultured from lower airway secretions of MV-ICU patients with or without VAP and compare them to isolates of the same species from their dental plaque.

This pilot study will enable this multidisciplinary team of investigators to organize the infrastructure, patient recruitment and methodologic protocols, and data management and analysis procedures necessary to perform a multi-center, controlled clinical trial to assess the efficacy and generalizability of this intervention to improve oral hygiene in MV-ICU and prevent VAP.

Eligibility

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

Criteria

Inclusion Criteria:

Patients included in this study will be those admitted to the trauma intensive care unit (TICU) of Erie County Medical Center (ECMC) hospital. All patients admitted to the TICU who are intubated and mechanically ventilated within 24-48 hours of admission will be eligible for study admission, with the exception of those demonstrating the following exclusion criteria: a) a witnessed aspiration (to eliminate patients with chemical pneumonitis); b) a confirmed diagnosis of post-obstructive pneumonia (e.g. advanced lung cancer); c) a known hypersensitivity to CHX; d) patients for whom consent can not be obtained; e) a diagnosed thrombocytopenia (platelet count less than 40 and/or a INR above 2) or other coagulopathy; f) a do not intubate order; g) children under the age of 18 years; h) Pregnant women; i) Legal incarceration; j) If transferred from another ICU; k) Those with oral mucositis; l) Those with immunosuppression (either-HIV or drug induced [e.g. organ transplant patients or those on long term steroid therapy]); m) Patients re-admitted to the TICU
Comatose and intubated patients will be included since they represent patients at greatest risk for respiratory infection.

Exclusion Criteria:

Patients for whom consent can not be obtained.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123123

Locations

United States, New York
University of Buffalo, The State University of New York
Buffalo, New York, United States, 14214

Sponsors and Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

Study Chair:	Frank A. Scannapieco, DMD PhD	University at Buffalo, The State University of New York
Principal Investigator:	Frank A. Scannapieco, DMD PhD	The State University of New York

More Information

No publications provided by National Institute of Dental and Craniofacial Research (NIDCR)

Publications automatically indexed to this study:

Heo SM, Haase EM, Lesse AJ, Gill SR, Scannapieco FA. Genetic relationships between respiratory pathogens isolated from dental plaque and bronchoalveolar lavage fluid from patients in the intensive care unit undergoing mechanical ventilation. Clin Infect Dis. 2008 Dec 15;47(12):1562-70.

Responsible Party:	University of Buffalo ( Frank A Scannapieco, DMD, Ph.D )
Study ID Numbers:	NIDCR-14685, 1R01-DE-14685-1A2
Study First Received:	July 21, 2005
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00123123
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Dental and Craniofacial Research (NIDCR):

Ventilator-associated pneumonia

Study placed in the following topic categories:

Chlorhexidine
Respiratory Tract Infections
Respiratory Tract Diseases
Chlorhexidine gluconate

Lung Diseases
Pneumonia, Ventilator-Associated
Cross Infection
Pneumonia

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Infective Agents, Local
Disinfectants
Therapeutic Uses

Infection
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2009