Clinical trial NCT00123123: Effect of Improved Oral Hygiene to Prevent Pneumonia in Hospitalized Patients
Official title: Oral Health and Ventilator-associated Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumonia
Keywords: Ventilator-associated pneumonia
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2005-07-22
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

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 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.

Primary outcomes:
measure: 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
timeFrame: Every 48 hours until discharge
Secondary outcomes:
measure: Clinical Pulmonary Infection Score (CPIS) at 48 Hours
timeFrame: 48 hours
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University of Buffalo, The State University of New York
state: New York
Study officials:
affiliation: University at Buffalo, The State University of New York
name: Frank A. Scannapieco, DMD PhD
role: STUDY_CHAIR
affiliation: The State University of New York
name: Frank A. Scannapieco, DMD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.