Usefulness and Feasibility of Ultrasound in Office Laryngology Procedures: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Quantitative clinician-reported usability measure of ultrasound during injection of the internal branch of superior laryngeal nerve for neurogenic cough.
研究概览
简要总结
Investigators will assess the usefulness of using ultrasound in office procedures for laryngology interventions. Participants who qualify will be adults who are undergoing superior laryngeal nerve block, injection laryngoplasty, swallowing evaluation, voice evaluation and voice therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •US-Guided Injection for Neurogenic Cough:
- •Age over 18 years
- •Recommended to undergo superior laryngeal nerve block
- •US-Assessment of Superior Laryngeal Nerve Anatomy
- •Age over 18 years
- •No cough complaints
- •US-Assessment of Injectate Volume:
- •Documentation of unilateral vocal fold paresis/paralysis or atrophy
- •Age over 18 years
- •Recommended to undergo injection laryngoplasty
- •US-Assessment of Swallow:
- •Age over 18 years
- •Presents with swallowing complaints
- •US-Assessment of Normal Swallow:
- •Age over 18 years
- •Presents without swallowing complaints
- •US-Assessment of Voice:
- •Age over 18 years
- •Undergoing evaluation of voice problems
排除标准
- •Age under 18 years and over 99 years
- •Open neck wound including tracheostomy
研究组 & 干预措施
Cough
Adult patients who are seen at the Sean Parker Institute for the Voice and are determined to have neurogenic cough for which superior laryngeal nerve block is recommended will undergo this procedure under ultrasound guidance. Patients without neurogenic cough will also be recruited for ultrasound assessment to establish landmarks and normal variation.
干预措施: Ultrasound for cough (Diagnostic Test)
Vocal Cord Atrophy
Adult patients with vocal fold atrophy, paresis, or paralysis diagnosed at the Sean Parker Institute for the Voice who are planned to undergo injection laryngoplasty will be invited to take part in the study.
干预措施: Ultrasound for vocal fold atrophy or vocal fold paresis/paralysis (Diagnostic Test)
Vocal Cord Paresis
Adult patients with vocal fold atrophy, paresis, or paralysis diagnosed at the Sean Parker Institute for the Voice who are planned to undergo injection laryngoplasty will be invited to take part in the study.
干预措施: Ultrasound for vocal fold atrophy or vocal fold paresis/paralysis (Diagnostic Test)
Dysphagia
Adult patients referred to the Sean Parker Institute for the Voice for swallowing assessment will undergo standard medical history including collection of age, gender, occupation, characteristics of swallowing complaints, and prior evaluation and treatments. Adult patients without swallowing complaints will also be recruited to define normal anatomy and variation.
干预措施: Ultrasound for dysphagia (Diagnostic Test)
Vocal Cord Paralysis
Adult patients with vocal fold atrophy, paresis, or paralysis diagnosed at the Sean Parker Institute for the Voice who are planned to undergo injection laryngoplasty will be invited to take part in the study.
干预措施: Ultrasound for vocal fold atrophy or vocal fold paresis/paralysis (Diagnostic Test)
Dysphonia
Adult patients referred to the Sean Parker Institute for the Voice for voice assessment will undergo standard medical history including collection of age, gender, occupation, characteristics of voice complaints, and prior evaluation and treatments. Additionally, patients diagnosed with muscle tension dysphonia will be evaluated by ultrasound for the presence, size, and function of their suprahyoid musculature.
干预措施: Ultrasound for dysphonia (Diagnostic Test)
结局指标
主要结局
Quantitative clinician-reported usability measure of ultrasound during injection of the internal branch of superior laryngeal nerve for neurogenic cough.
时间窗: Immediately post-intervention
The clinician will use the Likert scale and rate a series of statements on a scale of 1 (strongly disagree) to 5 (strongly agree). The lowest possible total score is 12 (overall clinician disagreement), and the highest possible total score is 60 (overall clinician agreement).
Qualitative clinician-reported usability measure of ultrasound during injection of the internal branch of superior laryngeal nerve for neurogenic cough.
时间窗: Immediately post-intervention
The clinician will respond to the following open-ended questions: * What are the benefits with performing the procedure with ultrasound? * What are the limitations with performing this procedure with ultrasound?
Patient comfort measures during ultrasound-guided injection of the internal branch of superior laryngeal nerve for neurogenic cough.
时间窗: Day 1
Number of patients that fall into the below categories as determined by the provider care team: * No discomfort: talking/comfortable throughout * Minimal discomfort: 1 or 2 episodes of mild discomfort with no distress * Mild discomfort: More than 2 episodes of discomfort without distress * Moderate discomfort: significant discomfort experienced several times with some distress * Severe discomfort: frequent discomfort with significant distress
Time to complete superior laryngeal nerve injection under ultrasound.
时间窗: Day 1
The amount of time will be recorded in minutes.
Images and descriptors of internal branch of superior laryngeal nerve anatomy and normal variation.
时间窗: Day 1
This is a qualitative outcome measure. Providers will provide a description of the internal branch of superior laryngeal nerve anatomy with accompanying images from the strobe.
Change in volume of injectate in injection laryngoplasty measured by ultrasound compared to amount injected after procedure and at follow-up.
时间窗: Immediately post-intervention and at 4 week follow-up visit
The volume will be recorded in mL.
Presence, bulk, and function of tongue, suprahyoid, and infrahyoid musculature on ultrasound for patients with and without swallowing complaints.
时间窗: Day 1
This is a qualitative outcome measure. Providers will provide a description of the tongue, suprahyoid, and infrahyoid musculature on ultrasound for patients with and without swallowing complaints.
Evaluation of suprahyoid musculature on ultrasound for patients with muscle tension dysphonia.
时间窗: Day 1
This is a qualitative outcome measure. Providers will provide a description of the suprahyoid musculature on ultrasound for patients with muscle tension dysphonia.
次要结局
未报告次要终点