Botulinum Toxin and Saliva Management in Tracheotomised Patients

• Status: Withdrawn
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HCA International Limited
• Treatments: Botulinum Toxins

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