Effect of daily application of a 0.05% chlorhexidine solution on the incidence of (aspiration) pneumonia in care home residents: design of a multicentre cluster randomised controlled clinical trial

INTRODUCTION: Pneumonia is an important cause of death in care home residents. Dysphagia and poor oral health are significant risk factors for developing aspiration pneumonia. Oral hygiene care reduces the number of oral bacteria and the risk of aspiration pneumonia. However, it is not clear yet which oral hygiene care intervention is most efficacious in reducing the risk of aspiration pneumonia. The aim of the study is to assess whether the application of a 0.05% chlorhexidine-containing solution in addition to the usual daily oral hygiene care reduces the incidence of pneumonia in physically disabled care home residents with dysphagia. METHODS AND ANALYSIS: The study was designed as a multicentre cluster randomised controlled clinical trial, with care homes as units of randomisation. During 1 year, 500 physically disabled care home residents with dysphagia will be followed. The intervention consists of applying a 0.05% chlorhexidine-containing solution twice daily, immediately after the usual oral hygiene care, whereas the control group receives no application after the usual oral hygiene care. The primary outcome is the incidence of pneumonia diagnosed by a physician, using a set of strictly described criteria. The effect of the intervention on the incidence of pneumonia will be determined using a Cox regression analysis. The secondary outcomes are correlations between incidence of pneumonia, age, gender, diagnosed diseases, dysphagia severity, care dependency, actually used medication, number of teeth and implants present and the presence of removable dentures. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Medical Ethical Committee of Radboud university medical centre: NL.nr: 41990.091.12. Written and informed consent will be obtained from all participating care homes and residents. The study's findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: The trial has been registered in the Netherlands in the National Trial Register: TC=3515.