Chlorhexidine Or toothpaSte, manual or powered brushing to prevent pNeumonia complicating stroke (CHOSEN): a 2x2 factorial randomised controlled feasibility trial

Abstract

Introduction: Increasing evidence links poor oral health status, dysphagia and development of stroke-associated pneumonia (SAP). The aim of this study is to determine whether a phase 3, randomised controlled trial of oral healthcare (OHC) to prevent SAP in dysphagic acute stroke patients is feasible.

Method: This is a randomised feasibility trial with parallel process evaluation. Using a factorial design, we plan to randomise 120 patients with acute stroke and dysphagia within 24 h of admission to either non-foaming toothpaste v 1% chlorhexidine gel and to either manual v powered brushing. Stroke unit nursing staff will receive standardised training to deliver the OHC treatments. Assessment of feasibility will include recruitment and set-up of sites, recruitment and retention of participants, adherence to allocated OHC treatment, acceptability and tolerability. We will also record incident SAP, antibiotic doses received, length of stay and modified Rankin score at 3 months. In the process evaluation we will focus on implementation of, and fidelity to, the OHC by undertaking focus groups at each site and employing behaviour change techniques to establish an implementation package.

Results: The trial commenced on 31st August 2021 at 4 North West hospitals with final 3 month follow-up at the end of March 2023.

Conclusion: We will establish whether feasibility progression criteria are met for a phase 3 trial, and whether further piloting is required.