Usefulness and Feasibility of Ultrasound in Office Laryngology Procedures

Not Applicable

Recruiting

• Conditions: Cough; Vocal Cord Atrophy; Dysphagia; Vocal Cord Paresis; Vocal Cord Paralysis; Dysphonia
• Interventions: Diagnostic Test: Ultrasound for cough; Diagnostic Test: Ultrasound for vocal fold atrophy or vocal fold paresis/paralysis; Diagnostic Test: Ultrasound for dysphagia; Diagnostic Test: Ultrasound for dysphonia

• Registration Number: NCT06579989
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-27
• Study First Posted: 2024-08-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-06
• Study Start: 2026-01
• Primary Completion: 2028-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• US-Guided Injection for Neurogenic Cough:

  1. Age over 18 years
  2. Recommended to undergo superior laryngeal nerve block

• US-Assessment of Superior Laryngeal Nerve Anatomy

  1. Age over 18 years
  2. No cough complaints

• US-Assessment of Injectate Volume:

  1. Documentation of unilateral vocal fold paresis/paralysis or atrophy
  2. Age over 18 years
  3. Recommended to undergo injection laryngoplasty

• US-Assessment of Swallow:

  1. Age over 18 years
  2. Presents with swallowing complaints

• US-Assessment of Normal Swallow:

  1. Age over 18 years
  2. Presents without swallowing complaints

• US-Assessment of Voice:

  1. Age over 18 years
  2. Undergoing evaluation of voice problems

Exclusion Criteria

1. Age under 18 years and over 99 years
2. Open neck wound including tracheostomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cough	Ultrasound for 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.
Vocal Cord Atrophy	Ultrasound for vocal fold atrophy or vocal fold paresis/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.
Vocal Cord Paresis	Ultrasound for vocal fold atrophy or vocal fold paresis/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.
Vocal Cord Paralysis	Ultrasound for vocal fold atrophy or vocal fold paresis/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.
Dysphagia	Ultrasound for 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.
Dysphonia	Ultrasound for 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.

Primary Outcome Measures

Name	Time	Method
Quantitative clinician-reported usability measure of ultrasound during injection of the internal branch of superior laryngeal nerve for neurogenic cough.	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.	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.	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.	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.	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.	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.	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.	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.

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States