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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 17 October 2012
Main ID:  NCT00973999
Date of registration: 08/09/2009
Primary sponsor: HCA International Limited
Public title: Botulinum Toxin and Saliva Management in Tracheotomised Patients
Scientific 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.
Date of first enrolment: September 2009
Target sample size: 0
Recruitment status: Withdrawn
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment  
Countries of recruitment
United Kingdom
Name:   Chetan Vyas, BSc, MSc
Affiliation:  HCA International Limited
Key inclusion & exclusion criteria

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

- 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

Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Traumatic Brain Injury
Drug: Botulinum Toxin
Primary Outcome(s)
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]
Secondary Outcome(s)
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]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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