CHOSEN trial

• Research type

  Research Study

• Full title

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

• IRAS ID

  270544

• Contact name

  Craig Smith

• Contact email

  craig.smith-2@manchester.ac.uk

• Sponsor organisation

  Salford Royal NHS Foundation Trust

• ISRCTN Number

  ISRCTN52421361

• Clinicaltrials.gov Identifier

  not applicable, not applicable

• Duration of Study in the UK

  1 years, 11 months, 31 days

• Research summary

  Aim: We want to find out whether cleaning the mouth after a stroke could reduce the likelihood of getting infections in the lung (pneumonia). Before we can test this in a large clinical trial, we need to conduct a smaller trial to check if our plans are achievable.

  Background: 100,000 people in the UK have a stroke each year. After a stroke it can be difficult for people to swallow or to keep their teeth and mouth clean. Together, these problems can lead to harmful bacteria building up in the mouth and causing pneumonia. As many people with stroke and swallowing problems suffer from pneumonia we want to know how best to keep their mouths clean when they are in hospital. At this stage, we don’t know which approach is best to prevent pneumonia, or even which approach is most suitable for people with stroke.

  Design and Methods: We will undertake a trial in stroke units at four hospitals. Nurses on the stroke units will receive training in how to deliver our mouth care intervention. 120 stroke patients with swallowing problems will be consented within 24 hours of coming into hospital and divided randomly into one of 4 groups:

  1. Toothpaste and manual toothbrush
  2. Toothpaste and powered toothbrush
  3. Antiseptic gel and manual toothbrush
  4. Antiseptic gel and powered toothbrush

  We will assess whether these mouth care treatments are feasible by looking at how many stroke patients agree to participate, how often they receive the treatment and how many complete the trial. We will see whether the treatments are acceptable by gathering the views of patients, their carers and the nursing staff. We will also collect information about how often pneumonia develops, how long participants stay in hospital, their quality of life and how well they recover. If this trial is positive, it will provide important information for a larger trial to see whether
  mouth care treatments can actually reduce the chances of pneumonia developing after stroke.

• REC name

  Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

• REC reference

  21/YH/0014

• Date of REC Opinion

  23 Mar 2021

• REC opinion

  Further Information Favourable Opinion