- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00123123
Effect of Improved Oral Hygiene to Prevent Pneumonia in Hospitalized Patients
Oral Health and Ventilator-associated Pneumonia
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
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Buffalo, New York, United States, 14214
- University of Buffalo, The State University of New York
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo (Vehicle Control)
Delivered Twice a day
|
|
Experimental: 0.12% chlorhexidine gluconate oral rinse
Delivered twice a day
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chlorhexidine gluconate oral rinse
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Experimental: 0.12% chlorhexidine oral rinse
Delivered once a day, placebo once a day
|
chlorhexidine gluconate oral rinse
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Colonization of the Oral Cavity by Respiratory Pathogens (on Teeth/Denture/Buccal Mucosa) as Determined by Quantitative Cultures Expressed as Colony Forming Units (Cfu) Per ml (CFU/mL) of the Aerobic Cultivable Flora After 48 Hours
Time Frame: Every 48 hours until discharge
|
Samples were diluted and plated on sheep's blood agar (to isolate S. aureus), and MacConkey agar (for isolation of Gram-negative bacilli) and incubated for 72 hours at 37°C in 5% carbon dioxide.
Plates were assessed for growth for the following target bacteria: S. aureus, P. aeruginosa, Acinetobacter species, and enteric organisms (Klebsiella pneumoniae, Serratia marcescens, Enterobacter species, Proteus mirabilis, Escherichia coli).
Results of quantitative cultures were expressed as colony forming units (cfu) per ml of sample.
|
Every 48 hours until discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Pulmonary Infection Score (CPIS) at 48 Hours
Time Frame: 48 hours
|
The CPIS score was calculated as follows: 1) Fever: 0 (36.5 to 38.4°C), 1 (38.5 to 39), 2 (<36.0 OR >39.0); 2) Leukocytosis: 0 (4000 to 11,000 white blood cells per mm3 of blood), 1 (11,000 to 17,000), 2 (>17,000); 3) New infiltrate: 0 = None, 1 = Patchy, 2 = Localized; 4) Secretions: 0 = None to minimal, 1 = moderate, 2 = large amount; and 5) PaO2/ FiO2: 0 = more than 330 and 2 = less than 330. Total scores for the subscales can range from 0-10, with lower scores indicating better outcome. |
48 hours
|
Collaborators and Investigators
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
Publications and helpful links
General Publications
- Scannapieco FA, Yu J, Raghavendran K, Vacanti A, Owens SI, Wood K, Mylotte JM. A randomized trial of chlorhexidine gluconate on oral bacterial pathogens in mechanically ventilated patients. Crit Care. 2009;13(4):R117. doi: 10.1186/cc7967. Epub 2009 Jul 15.
- 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. doi: 10.1086/593193.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIDCR-14685
- R01DE014685 (U.S. NIH Grant/Contract)
- 1R01-DE-14685-1A2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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