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临床试验/NCT05493397
NCT05493397已完成不适用

A Feasibility Study to Investigate the Accuracy and Viability of Ultrasound in Detecting Impairments of Vocal Fold Mobility in People With Neurological Disease

University College, London1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Accuracy of transcutaneous laryngeal US in the diagnosis of vocal fold movement impairment in patients with neurological disease.

研究概览

简要总结

This study aims to investigate the accuracy and viability of transcutaneous laryngeal ultrasound (US) in detecting impairments of vocal fold movement in people with neurological disorders.

The accuracy and viability of laryngeal US compared with reference standard fibreoptic nasendoscopic examination (FNE) will be evaluated. The study also includes measurements of clinician reliability in US image acquisition and interpretation, and assess the acceptability of US assessment to people with neurological disorders. Data will be used to assess the ability of US to detect other laryngeal pathology, and to calculate the sample size required for a validation study.

详细描述

The availability of cheaper and more portable ultrasound (US) machines has resulted in the extension of the use of US beyond the radiology department into diverse clinical areas. In particular, the Covid-19 pandemic has intensified interest in US as an alternative tool to use within the Speech and Language Therapy (SLT) profession to assess swallowing and airway disorders as access to routine assessment tools such as fibreoptic endoscopic examination (FNE) was restricted to its due aerosol-generating properties (Bolton et al., 2020).

The use of US by allied health professionals, such as Speech and Language Therapists (SLTs), is driven by National Institute for Health and Care Excellence (NICE) guidance and government policy (The Royal College of Radiologists, 2017) whereby the range of applications and locations where US can be used makes it impractical to deliver this imaging using radiologists or sonographers alone.

The application of laryngeal US is not new within the medical profession and there is considerable mounting evidence to support both the diagnostic ability and feasibility of laryngeal US for diagnosing impairments of vocal fold movement. Laryngeal US has been found to have both high sensitivity and specificity in diagnosing disorders of vocal fold movement in the post-surgical (specifically thyroid) population. Findings of a recent rapid review exploring the utility of laryngeal US for the assessment of vocal fold function revealed a sensitivity and specificity of 100% to detect normal versus disordered vocal fold function with a linear probe with range frequencies (e.g.6-13Hz) (Allen et al., 2020). To date, there are no studies exploring use of laryngeal US in assessing vocal fold movement in neurological conditions, despite the prominence of vocal fold impairments in this patient group.

In addition to increased accuracy, laryngeal US has many other advantages as an assessment and monitoring tool. Arguably, the greatest advantage of laryngeal US over FNE is its bedside accessibility and potential avoidance of intrusive procedures. This is particularly paramount in patients that require multiple invasive procedures, for example, combined FNE and non-invasive ventilation, cough augmentation, suction, nasogastric tube feeding and high flow oxygen therapy. Furthermore, if evaluation by laryngeal US was led by SLT, it would not require patient transport to Ear, Nose & Throat (ENT) clinics or presence of an ENT consultant at bedside; potentially expediting access to diagnosis of vocal fold function impairments and reducing cost.

A trained SLT could utilise US to identify presence or absence of vocal fold function impairment in patients with neurological disease. Primary examples are cases where vocal fold impairment is a known or anticipated symptom of the underlying neurological condition (such as brainstem stroke, multiple system atrophy and/or neuromuscular conditions such as Charot Marie Tooth disease). In these cases, the SLT could assess using laryngeal US to ascertain a vocal fold diagnosis to inform timely management or treatment plan. In cases where intrusive respiratory interventions may provoke issues with vocal fold movement (such as cough augmentation) the SLT can provide non-invasive 'real-time' monitored laryngeal US assessment which will directly influence combined SLT and physiotherapy management in patients with combined bulbar and respiratory disease. They could also use US to inform the relative urgency of subsequent ENT opinion. This is particularly pertinent at NHNN where there is no on-site access to ENT.

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

入选标准

  • Patients under in-patient our out-patient Speech and Language Therapy care at primary study site.
  • Patients with a neurological condition who have a suspected impairment of vocal fold movement due to diagnosis of dysphonia, breathing difficulties and/or impaired cough as determined by their lead Speech and Language Therapist.
  • Over 18 years old
  • Has undergone/will undergo nasendoscopy as part of their standard clinical care.

排除标准

  • Patients who cannot be supported to demonstrate capacity to consent.
  • Any patient that automatically meets the clinical exclusion criteria for FNE; e.g. epistaxis risk, facial fracture, patient distress.
  • Patients who do not have sufficient command of English to consent in this study will also be excluded from the study due to limited resources for advocacy services. Participants will require sufficient English language skills to participate in the patient questionnaire.

结局指标

主要结局

Accuracy of transcutaneous laryngeal US in the diagnosis of vocal fold movement impairment in patients with neurological disease.

时间窗: 12 months

Each participant with be assessed using i) laryngeal ultrasound (US) and ii) fibreoptic nasendoscopic examination (FNE). One ENT or SLT will pass an FNE to assess vocal fold function. Images will be interpreted by an ENT consultant blinded to the outcomes of the laryngeal US. Two blinded SLTs will capture and interpret laryngeal US images. Each SLT will be blinded to the outcomes of i) the FNE assessment and ii) their SLT peer US assessment. Vocal fold movement will be assessed using a three-point scale (0 - normal movement, 1- impaired movement, 2- no movement). Descriptive and inferential statistics will be used to establish the sensitivity and specificity of laryngeal US in detecting an impairment of vocal fold movement impairment. A consensus agreement between the two blinded SLTs will be used to calculate the sensitivity and specificity.

Technical and environmental viability of laryngeal US in patients with neurological disease.

时间窗: 12 months

Image acquisition scored on a binary scale (possible/not possible). Any technical or environmental factors preventing US image acquisition will be captured on a pre-determined spread sheet.

次要结局

  • Reliability of assessors in capturing and interpreting laryngeal US images for the purpose of vocal fold movement assessment in patients with neurological disease.(15 months)
  • Acceptability of transcutaneous laryngeal US to patients with neurological disease.(15 months)
  • Diagnostic accuracy and feasibility of laryngeal US between patients of different neurological disease groups(15 months)
  • Ability of US to detect other laryngeal pathology in patients with neurological disease.(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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