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临床试验/NCT01784224
NCT01784224已完成不适用

A Comparison of the Blom Low Profile Voice Inner Cannula and the Passy-Muir One-Way Tracheotomy Tube Speaking Valve on Voice Production, Speech Intelligibility, and Biomechanical Swallowing Behavior

Yale University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Maximum Duration of Voicing (seconds)

研究概览

简要总结

The main purpose of this study is to investigate voice production, speech intelligibility and routine physiologic parameters associated with the Blom low profile voice inner cannula and the Passy-Muir one-way tracheotomy tube speaking valves.

Additionally, the purpose of this study is to investigate the effects (if any) associated with the Blom low profile voice inner cannula and the Passy-Muir one-way tracheotomy tube speaking valves on swallowing behavior and biomechanical movement of the hyolaryngeal complex during routine diagnostic modified barium swallowing evaluations.

详细描述

The goal of a one-way tracheotomy tube speaking valve is to allow cognitively intact individuals who require a tracheotomy tube communicate with their own voice. All non-verbal communication strategies have shortcomings. Lip reading is unreliable, communication boards are simplistic, writing very laborious, and computerized augmentative communication systems too costly. This inability to communicate effectively prevents optimal patient participation in their plan-of-care. Verbal communication, therefore, plays an integral role in psychological functioning, social interactions, and overall medical care.

The primary criteria for determining success or failure of any one-way tracheotomy tube speaking valve is how well it allows for adequate voice intensity greater than ambient room noise to achieve both audible voice production and intelligible speech. The first purpose of this study is to investigate voice production and speech intelligibility abilities associated with the Blom low profile voice inner cannula and the Passy-Muir one-way tracheotomy tube speaking valves. It is hypothesized that there will be no significant differences between the two speaking valves regarding physiologic parameters, voice production, or speech intelligibility capabilities.

There are conflicting reports in the literature regarding the relationship between a tracheotomy tube and swallowing success. Some authors report an improvement in swallowing success when the tracheotomy tube is occluded while others report no change in aspiration status based on occlusion status of the tracheotomy tube. Recently, it has been reported that there was no causal relationship between the tracheotomy tube and aspiration status. There is a paucity of research, to date, reporting on movement of the hyolaryngeal complex based upon occlusion status of a tracheotomy tube or presence of a tracheotomy tube. The second purpose of this study is to investigate how the Blom low profile voice inner cannula and the Passy-Muir one-way tracheotomy tube speaking valves impact on swallowing behavior and movement of the hyolaryngeal complex during routine diagnostic modified barium swallow evaluations.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over 18 years of age, English speaking, and ability to tolerate a tracheotomy tube with a fully deflated tracheotomy tube cuff.

排除标准

  • Inability to tolerate full tracheotomy tube cuff deflation or copious secretions preventing placement of a one-way tracheotomy tube speaking valve.

结局指标

主要结局

Maximum Duration of Voicing (seconds)

时间窗: 30 minutes

Maximum duration of voicing (seconds) will be obtained, after instructing the patient to say the vowel /a/ as long as possible timed with a stopwatch.

Maximum Voice Intensity (dBA scale)

时间窗: 30 minutes

Maximum voice intensity (on the dBA scale) will be obtained, after instructing the patient to say the vowel /a/ as loud as possible, using a digital sound level meter placed 15 cm from the patient's lips.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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