Terminé

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

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Ce qui est testé

Collecte de données

Qui peut participer

Processus pathologiques

+ Maladie Critique
+ Attributs de la maladie
À partir de 18 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Phase 3
Interventionnel
Date de début : mars 2004
Voir le détail du protocole

Résumé

Sponsor principalNational Institutes of Health Clinical Center (CC)
Dernière mise à jour : 18 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer cette étude
Date de début de l'étude : 2 mars 2004Date à laquelle le premier participant a commencé l'étude.

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.

Titre officielThe Effect of a Systemic Oral Care Program on Reducing Exposure to Oropharyngeal Pathogens in Critically III Patients 
NCT00078663
Sponsor principalNational Institutes of Health Clinical Center (CC)
Dernière mise à jour : 18 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer cette étude

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design
800 participants à inclureNombre total de participants que l'essai clinique vise à recruter.
Traitement
Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères
Tout sexeLe sexe biologique des participants éligibles à s'inscrire.
À partir de 18 ansTranche d'âge des participants éligibles à participer.
Volontaires sains non autorisésIndique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.
Conditions
Pathologie
Processus pathologiques
Maladie Critique
Attributs de la maladie
Critères

* 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.

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.
Cette étude comporte 5 sites
Suspendu
Washington Hospital CenterWashington, D.C., United StatesVoir le site
Suspendu
Suburban HospitalBethesda, United States
Suspendu
National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, United States
Suspendu
Inova Fairfax HospitalFairfax, United States
Terminé5 Centres d'Étude