Botulinum Toxin and Saliva Management in Tracheotomised Patients

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
HCA International Limited
ClinicalTrials.gov Identifier:
NCT00973999
First received: September 8, 2009
Last updated: September 5, 2012
Last verified: September 2009
  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.

Resource links provided by NLM:


Further study details as provided by HCA International Limited:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973999

Locations
United Kingdom
The Wellington Hospital
London, United Kingdom, NW8 9LE
Sponsors and Collaborators
HCA International Limited
Investigators
Principal Investigator: Chetan Vyas, BSc, MSc HCA International Limited
  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 September 22, 2014