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.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The weight of intra-orally placed dental rolls
研究概览
简要总结
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
详细描述
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.
Protocol Number: Version 5, 20th July 2009
HCA reference: CTO/09/032
EudraCT reference: 2009-011204-27
This protocol describes the Botulinum toxin and Saliva management study and provides information about procedures for entering participants. Every care was taken in its drafting, but corrections or amendments may be necessary. These will be circulated to investigators in the study. Problems relating to this study should be referred, in the first instance, to the Chief Investigator. This study will adhere to the principles outlined in the NHS Research Governance Framework for Health and Social Care (2nd edition). It will be conducted in compliance with the protocol, the Data Protection Act and other regulatory requirements as appropriate
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Myocardial Infarction
- •Heart Disease
- •Head or neck surgery
- •Acute or progressive neurological disease
- •Structural abnormalities that may affect swallowing
研究组 & 干预措施
Injection into salivary gland
干预措施: Botulinum Toxin (Drug)
结局指标
主要结局
The weight of intra-orally placed dental rolls
时间窗: participants will be followed for the duration of hospital stay, an expected average of 12 weeks
次要结局
- 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)