Botulinum Toxin and Saliva Management in Tracheotomised Patients

NCT00973999 | Withdrawn Phase 2 DMC

• 1 other identifier: CTO/09/032
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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. 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

Conditions

Traumatic Brain Injury

Keywords

Botulinum Toxin; Saliva; Tracheostomy tube

Outcome Measures

Primary Outcomes (1)

• The weight of intra-orally placed dental rolls

  participants will be followed for the duration of hospital stay, an expected average of 12 weeks

Secondary Outcomes (1)

• Observational tally of number of tracheal suctions performed over a 12-hour period.

  participants will be followed for the duration of hospital stay, an expected average of 12 weeks

Study Arms (1)

Injection into salivary gland

EXPERIMENTAL

Drug: Botulinum Toxin

Interventions

Botulinum Toxin DRUG

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.

Also known as: Dysport, Ipsen Limited.

Injection into salivary gland

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HCA International Limited: lead

Study Sites (1)

The Wellington Hospital

London, NW8 9LE, United Kingdom

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Botulinum Toxins; abobotulinumtoxinA

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Chetan Vyas, BSc, MSc

  HCA International Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2009
• First Posted: September 9, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 6, 2012

Record last verified: 2009-09

Locations

GB (1)