Status:
WITHDRAWN
Botulinum Toxin and Saliva Management in Tracheotomised Patients
Lead Sponsor:
HCA International Limited
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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. DES...
Detailed Description
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. Protocol N...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00973999
Start Date
September 1 2009
End Date
September 1 2011
Last Update
September 6 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Wellington Hospital
London, United Kingdom, NW8 9LE