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Botulinum Toxin and Saliva Management in Tracheotomised Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00973999
Recruitment Status : Withdrawn
First Posted : September 9, 2009
Last Update Posted : September 6, 2012
Information provided by:
HCA International Limited

Brief Summary:


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
  • 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.


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

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Drug: Botulinum Toxin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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.
Study Start Date : September 2009
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00973999

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United Kingdom
The Wellington Hospital
London, United Kingdom, NW8 9LE
Sponsors and Collaborators
HCA International Limited
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Principal Investigator: Chetan Vyas, BSc, MSc HCA International Limited
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Responsible Party: Mr. Chetan Vyas, HCA International Ltd. Identifier: NCT00973999    
Other Study ID Numbers: CTO/09/032
First Posted: September 9, 2009    Key Record Dates
Last Update Posted: September 6, 2012
Last Verified: September 2009
Keywords provided by HCA International Limited:
Botulinum Toxin
Tracheostomy tube
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs