Feasibility and Intelligibility Testing of a Microphone System to Facilitate Patient Communication During Noninvasive Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Rating of speech intelligibility
研究概览
简要总结
Assessing speech intelligibility in a pilot study of patients speaking with a mask microphone while being treated with standard of care non-invasive ventilation. This is a feasibility study to test the microphone in a real world setting.
详细描述
We will conduct a prospective feasibility study to evaluate speech intelligibility of 10 patients (target distribution of gender: 5 males, 5 females) undergoing standard of care, clinically indicated non-invasive ventilation. Patients will be their own control with and without the ReddyPort™ microphone using a crossover design, with the sequence of conditions randomized (half of patients start with microphone turned on, half start with the microphone turned off). The patients in this study will all receive standard of care. No medical decisions for a change in care will result from the speech recordings obtained during this feasibility study. The speech recordings will be analyzed off-site using a pool of blinded volunteers. The microphone on and off test conditions will not be used to change outcome of the clinical course of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 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
- 否
入选标准
- •Age greater than or equal to 18 years
- •Currently hospitalized
- •Awake and able to attempt communication
- •Respiratory failure requiring non-invasive ventilatory support
- •Positive Inspiratory Pressure (PIP) less than or equal to 20 cm H2O
- •Positive End Expiratory Pressure (PEEP) less than or equal to 10 cm H2O
- •FiO2 less than or equal to 0.60
- •Clinical attending physician believes it is safe for the patient to participate
- •Able to consent o If patient cannot consent on the basis of difficulty in being heard and asking questions (as in fact may occur with NIV, a key assumption of this study), then assent will be obtained from the patient with informed consent obtained from a legally authorized representative.
排除标准
- •Tachypnea with RR > 35
- •Increase in PIP, PEEP or FiO2 over the last 2 hours
- •Known to be delirious (clinically obtained CAM score that is positive)
研究组 & 干预措施
Arm 1
Patient talking with microphone first turned on and then off
干预措施: Noninvasive Ventilation Mask Microphone (Device)
Arm 2
Patient talking with microphone first turned off and then on
干预措施: Noninvasive Ventilation Mask Microphone (Device)
结局指标
主要结局
Rating of speech intelligibility
时间窗: Intelligibility will be rated offline by blinded listeners who hear the recording 1-12 weeks after speaking tasks are complete.
The 1-5 likert scale developed by Yorkston et al will be used to evaluate speech intelligibility of the device (Yorkston, Kathryn M., David R. Beukelman, and Charles Traynor. Assessment of intelligibility of dysarthric speech. Austin, TX: Pro-ed, 1984.Powell TW. A comparison of English reading passages for elicitation of speech samples from clinical populations. Clin Linguist Phon. 2006;20(2-3):91-7)
次要结局
- Rating of microphone likability(Immediately after speaking tasks are complete)
- Rating of speech comprehensibility(Immediately after speaking tasks are complete)
- Rating of how natural the speech sound quality is(Immediately after speaking tasks are complete)
研究者
Sarah Ferguson
Associate Professor
University of Utah