Is Laryngeal Ultrasound a Useful Tool in the Assessment of Inducible Laryngeal Obstruction? A Protocol for a Two-stage Exploratory Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the sensitivity, specificity and positive predictive value of the use of ultrasound
研究概览
简要总结
This study is a feasibility study to see if an ultrasound scan of the vocal cords can detect narrowing of the vocal cords as seen in a condition called inducible laryngeal Obstruction (the vocal cords narrow or close on breathing in, which makes it very difficult to breathe).
详细描述
This study aims to help understand whether viewing the vocal cords with an ultrasound device is useful to detect the movement of the vocal cords during breathing. This study is useful, as some people who have abnormal movements of the vocal cords on breathing in find it more difficult to breathe in, and often this leads to a big impact on their quality of life. It may also mean they are on medications that they may not need not be on, as abnormal movements of the vocal cords can often be mistaken for asthma, so they may have been placed on asthma medication when they may not need to be.
Usually, the way the abnormal movements of the vocal cords are seen now is via a small camera is placed via the nose into the throat to directly look at the vocal cords. Some people find this uncomfortable and may have to wait for a long time for it to happen. Also, this procedure is expensive, and is done in an endoscopy theatre, which may make it more daunting for some people, and make the wait longer. There are only a few centres that do these assessments with the camera, so people may have to travel some distance to have an assessment.
It is hoped, by doing this study, the investigators can see whether ultrasound can help assess if people have abnormal vocal cord movements when they breathe in. This will be done in 2 stages, one with healthy volunteers, and the second stage in patients who have been referred for assessment of their vocal cords to see if they have abnormal movements when breathing in. The investigators will also ask the volunteers and patients what their experience of having the ultrasound was like, and will ask the patients in the study how the ultrasound scan felt, when compared to the camera test
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers:
- •No definite signs or symptoms of vocal fold paralysis
- •No voice change
- •No history laryngeal surgeries
- •No History of pathology
- •No uncontrolled Respiratory disease
排除标准
- •Participants with a known vocal fold pathology
- •Participants with a history of head and neck surgery.
结局指标
主要结局
To assess the sensitivity, specificity and positive predictive value of the use of ultrasound
时间窗: 1 day
To assess the sensitivity, specificity and positive predictive value of the use of ultrasound in the assessment of ILO, using Laryngoscopy as reference standard in the patient population (n=30)
Number of particpants where visualisation of mimicked inspiratory adduction is visible on ultrasound
时间窗: 1 day
Can the vocal cords be seen to adduct under TLUS when healthy volunteers mimic ILO? Binary outcome: yes or no.
Number of vocal cords that are seen with the ultrasound
时间窗: 1 day
Can the vocal cord be seen under TLUS for Healthy Volunteers? Numeric data.
Questionnaire Investigating user perspectives on the acceptability of TLUS
时间窗: 1 day
A qualitative questionnaire investigating the patient and healthy volunteer perspectives on their experiences of undergoing TLUS assessment of the vocal cords. The questionnaire will look at the acceptability of the assessment in terms of comfort, repeatability, and comparison with laryngoscopy (for patients only).
次要结局
未报告次要终点
研究者
Claire Slinger
Consultant Speech & Language Therapist
Lancashire Teaching Hospitals NHS Foundation Trust
