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
Ventilator-associated pneumonia	Drug: chlorhexidine gluconate oral rinse (0.12%)	Phase II

Further Study Details: 

Primary Outcomes: Colonization of the oral cavity by target respiratory pathogens (teeth/denture/buccal mucosa) at >1% of the aerobic cultivable flora.
Secondary Outcomes: The CPIS system will be used to calculate a CPIS score. This system is based on five different elements:; a) Pao2/Fio2; b) Infiltrate on CXR; c) Leukocytosis; d) purrulent secretions; e) fever.
Expected Total Enrollment:  250

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients included in this study will be those admitted to the trauma ICU of 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00123123

Frank A. Scannapieco, DMD, Ph.D.      716-829-3373    fas1@buffalo.edu

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

Study chairs or principal investigators

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

Study ID Numbers:  NIDCR-14685; 1R01-DE-14685-1A2
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 21, 2005
ClinicalTrials.gov Identifier:  NCT00123123
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-26