Effect of Improved Oral Hygiene to Prevent Pneumonia in Hospitalized Patients

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT00123123
First received: July 21, 2005
Last updated: August 12, 2010
Last verified: August 2010
  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%)
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Oral Health and Ventilator-associated Pneumonia

Resource links provided by NLM:


Further study details as provided by State University of New York at Buffalo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Clinical Pulmonary Infection Score (CPIS) at 48 Hours [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

    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.



Enrollment: 175
Study Start Date: March 2004
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo (Vehicle Control)
Delivered Twice a day
Drug: placebo
Experimental: 0.12% chlorhexidine gluconate oral rinse
Delivered twice a day
Drug: chlorhexidine gluconate oral rinse (0.12%)
chlorhexidine gluconate oral rinse
Experimental: 0.12% chlorhexidine oral rinse
Delivered once a day, placebo once a day
Drug: chlorhexidine gluconate oral rinse (0.12%)
chlorhexidine gluconate oral rinse
Drug: placebo

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
State University of New York at Buffalo
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

Publications:
Responsible Party: Frank A Scannapieco, DMD, Ph.D, University of Buffalo
ClinicalTrials.gov Identifier: NCT00123123     History of Changes
Other Study ID Numbers: NIDCR-14685, R01DE014685, 1R01-DE-14685-1A2
Study First Received: July 21, 2005
Results First Received: August 12, 2010
Last Updated: August 12, 2010
Health Authority: United States: Federal Government

Keywords provided by State University of New York at Buffalo:
Ventilator-associated pneumonia

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
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on April 21, 2014