Botulinum Toxin and Saliva Management in Tracheotomised Patients
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Traumatic Brain Injury |
Drug: Botulinum Toxin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Subject) 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Injection into salivary gland
not applicable
|
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.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study
- Male or female participants over the age of 18 years
- Participants who have a tracheostomy tube in-situ
- Participants who are breathing on room air, without the need for any mechanical ventilation
- Participants who require tracheal suctioning in order to maintain a clear airway
Exclusion Criteria:
- Patients presenting with any of the following exclusion criteria will not be included in the study
- Contra-indications to the use of Botulinum Toxin
- Receiving medications that may react with Botulinum Toxin, such as aminoglycosides (e.g., gentamicin), anticholinesterase medicines (e.g., neostigmine), lincosamides (e.g., clindamycin), magnesium, neuromuscular blockers (e.g., atracurium), polymyxin, or quinidine because the risk of toxic effects may be increased
- Receiving anticoagulants medication (e.g., warfarin)
- Expectant mothers
Previous history of:
- Swallowing disorders
- Stroke
- Myocardial Infarction
- Heart Disease
- Head or neck surgery
- Acute or progressive neurological disease
- Structural abnormalities that may affect swallowing
Contacts and Locations More Information
No publications provided
| Responsible Party: | Mr. Chetan Vyas, HCA International Ltd. |
| ClinicalTrials.gov Identifier: | NCT00973999 History of Changes |
| Other Study ID Numbers: | CTO/09/032 |
| Study First Received: | September 8, 2009 |
| Last Updated: | September 5, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by HCA International Limited:
|
Botulinum Toxin Saliva Tracheostomy tube |
Additional relevant MeSH terms:
|
Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System |
Wounds and Injuries Botulinum Toxins Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013