Plaque control to reduce ventilator associated pneumonia

Objectives: Inadequate oral care has been suggested as a potential risk factor for the development of ventilator associated pneumonia (VAP). The purpose of this presentation is to discuss issues inherent in designing a clinical trial in a critical care facility. Methods: A randomised controlled trial was designed to test the efficacy of dental plaque removal on the colonisation of dental plaque by ventilator associated pneumonia (VAP) organisms and incidence of VAP. Key design issues were; determining sample size, managing assent/consent with critically ill participants, selection of outcomes of importance in relation to VAP, designing interventions which were practical to investigate in a critical care facility and provision of training for care-givers and examiners. Results: For this pilot study, microbiological data were selected as the surrogate primary endpoint with data safety monitoring of incidence of VAP and mortality. Sample size was determined from systematically reviewing the literature and employing previously reported microbiological data. Choice of interventions was informed by discussion with the critical care nurses who will provide the oral health care in this setting taking into account frequency of delivery and problems related to access due to intubation and consciousness of participants. Training of caregivers has been designed to allow for teams of caregivers to be trained and monitored. Conclusions: Running clinical trials in critical care facilities provides new challenges to oral health researchers and can be achieved by collaboration and integration of medical, nursing and oral health teams.