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Botulinum Toxin and Saliva Management in Tracheotomised Patients

NCT00973999 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2012-09-06

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • HCA International Limited

    lead OTHER

Principal Investigators

  • Chetan Vyas, BSc, MSc · HCA International Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00973999 on ClinicalTrials.gov