Botulinum Toxin and Saliva Management in Tracheotomised Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00973999
• Date of registration: 08/09/2009
• Prospective Registration: No
• 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• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT00973999
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United Kingdom

Contacts

• 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
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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Traumatic Brain Injury

Intervention(s)

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)

CTO/09/032

Source(s) of Monetary Support

Please refer to primary and secondary sponsors