Botulinum Toxin and Saliva Management in Tracheotomised Patients

TITLE A randomised placebo controlled trial to explore the effectiveness of Botulinum Toxin injection at reducing oral secretions and frequency of tracheal suctioning in tracheotomised patients. DESIGN Randomised controlled single blinded experimental design AIMS The purpose of this study is to determine if ultra-sounded guided injections of Botulinum Toxin into the salivary glands (Parotid and sub-mandibular glands) of patients with a tracheostomy tube in-situ assists in the reduction of oral secretions. OUTCOME MEASURES Amount of saliva production / frequency of tracheal suctioning / questionnaires. POPULATION In-patients at the Wellington Hospital based in London will be invited to participate within the study. Participants will be recruited from a range of wards which will include the Intensive Treatment Unit (ITU), acute medical wards and rehabilitation wards. All participants will have a tracheostomy tube in-situ and be breathing on room air, without the need for any mechanical ventilation. Participants will be receiving tracheal suctioning to assist in the clearance of saliva to maintain a clear airway. A total of 40 participants will be recruited to the study across a two year period. Each participant will have no prior history of the following: * swallowing disorders * stroke * myocardial infarction * head or neck surgery * respiratory disease * acute or progressive neurological disease * structural abnormalities that could affect swallowing * other medical conditions requiring medication that could affect swallowing. ELIGIBILITY Male and female adults over the age of 18 years TREATMENT Injection of Botulinum Toxin into both pairs of the parotid salivary glands and submandibular glands, using ultrasound guidance DURATION Data collection over a two year period / six weeks for each participant