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The Effect of a Systemic Oral Care Program on Reducing Exposure to Oropharyngeal Pathogens in Critically III Patients

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Procesos Patológicos

A partir de 18 años
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Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 3
Intervencional
Inicio del estudio: marzo de 2004
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Resumen

Patrocinador PrincipalNational Institutes of Health Clinical Center (CC)
Última actualización: 18 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio
Fecha de inicio: 2 de marzo de 2004Fecha en la que se inscribió al primer participante.

Critically ill patients, especially those that require endotracheal intubation, have the greatest risk of any hospitalized patient for acquiring nosocomial pneumonia. Nosocomial pneumonia, in this population, produces a substantial increase of mortality and morbidity. The literature suggests the causative pathway is aspiration of oropharyngeal pathogens found in dental plaque. The build-up of dental plaque has been significantly associated with subsequent nosocomial respiratory infections. Thus, prevention of pathogens colonization in the oropharyngeal cavity could be an effective infection control measure. Dental plaque once it reaches a critical thickness, acts as a reservoir for both aerobic and anaerobic pathogens. Failure to remove plaque begins a complex cascade of biological activity by which pathogens adhere to mucosal and tooth surfaces and pathogen overgrowth ensues. Additionally, neglected or insufficient mouth care is the foremost predisposing factor to oral conditions such as gingivitis, mucositis, and stomatitis which supply additional ports of entry for pathogens. There are only a handful of studies that compare the frequency and type of oral hygiene required to prevent or decrease oropharyngeal colonization. A recent pilot study, 01-CC-0207, compared oral care provision in two intensive care units (ICU) in the Clinical Center. The test ICU offered meticulous oral hygiene through a system of regular oral assessments taught by a dentist and dental hygienist. The score from the assessment determined the type and frequency of oral care. The control ICU gave standard care typical of the ICU community. Plaque and saliva assays were collected from the enrolled patients. Significantly lower Beck scores and lower colony forming organisms in the specimens was achieved in the test ICU on day 3, p less than 0.03 and p less than 0.001 respectively. This protocol will expand the pilot into a prospective randomized assigned trial conducted at four hospitals in the Washington D.C. area. These hospitals have ICUs more representative of ICU's nation-wide. This study will test the effectiveness of a comprehensive and systematic oral care program to reduce the oral assessment scores, mucosal plaque scores, and the amount of pathogen inoculum present in the saliva and plaque. Intubated and non-intubated patients will be compared as well as meticulous care with or without the addition of the oral antiseptic, chlorhexidine. Consistency of practice performance will also be evaluated when nursing staff has dentist/hygienist instruction and monitoring versus the traditional nurse instruction.

Título OficialThe Effect of a Systemic Oral Care Program on Reducing Exposure to Oropharyngeal Pathogens in Critically III Patients 
NCT00078663
Patrocinador PrincipalNational Institutes of Health Clinical Center (CC)
Última actualización: 18 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño
Se reclutarán 800 pacientesNúmero total de participantes que el ensayo clínico espera reclutar.
Estudio de Tratamiento
Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios
Cualquier sexoSexo biológico de los participantes elegibles para inscribirse.
A partir de 18 añosRango de edades de los participantes que pueden unirse al estudio.
Voluntarios sanos no permitidosIndica si personas sanas, sin la condición que se estudia, pueden participar.
Condiciones
Patología
Procesos Patológicos
Criterios

* INCLUSION CRITERIA: * Male or female adult ICU patients whose oral hygiene is dependent upon hospital care providers. * Expected length of ICU stay is greater than or equal to 3 days. * Any gender and ethnicity. EXCLUSION CRITERIA: * Individuals and or responsible family members who are unable to provide consent. * Any individual under the age of 18 years. * Any individual whose expected admission is less than 3 days. * Adult ICU patients whose admission CPIS score is greater than 6. * Individuals who are able to provide own oral care. * Individuals who have oral surgery that requires specialized oral care and assessment. * Edentulous patients. * Any patient with a prosthetic heart valve or who routinely takes prophylactic antibiotics before routine dental procedures. * Any patient with a known allergy to chlorhexidine.

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.
Este estudio tiene 5 ubicaciones
Suspendido
Washington Hospital CenterWashington, D.C., United StatesVer ubicación
Suspendido
Suburban HospitalBethesda, United States
Suspendido
National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, United States
Suspendido
Inova Fairfax HospitalFairfax, United States
Completado5 Centros de Estudio