Botulinum Toxin and Saliva Management in Tracheotomised Patients
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.
Randomised controlled single blinded experimental design
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.
Amount of saliva production / frequency of tracheal suctioning / questionnaires.
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
- 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.
Male and female adults over the age of 18 years
Injection of Botulinum Toxin into both pairs of the parotid salivary glands and submandibular glands, using ultrasound guidance
Data collection over a two year period / six weeks for each participant
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
|Official 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.|
- The weight of intra-orally placed dental rolls [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
- Observational tally of number of tracheal suctions performed over a 12-hour period. [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||September 2011|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
|Experimental: Injection into salivary gland||
Drug: Botulinum Toxin
Each parotid salivary gland will be injected with 75MU of Botulinum Toxin type-A, 0.15mls in total, with 0.09mls into the mass of the gland and another 0.06mls into the adjacent part above the masseter muscle, using a 1ml syringe and a 30 gauge needle.
Each submandibular salivary gland will be injected with 15MU of Botulinum Toxin A, administering 0.03mls, using a 1ml syringe and a 30 gauge needle.
Other Name: Dysport, Ipsen Limited.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00973999
|The Wellington Hospital|
|London, United Kingdom, NW8 9LE|
|Principal Investigator:||Chetan Vyas, BSc, MSc||HCA International Limited|