Usefulness and Feasibility of Ultrasound in Office Laryngology Procedures

NCT06579989 | Not Yet Recruiting

• 1 other identifier: 23-10026663
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cough; Vocal Cord Atrophy; Vocal Cord Paresis; Vocal Cord Paralysis; Dysphagia; Dysphonia

Outcome Measures

Primary Outcomes (8)

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

  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).

  Immediately post-intervention

• Qualitative clinician-reported usability measure of ultrasound during injection of the internal branch of superior laryngeal nerve for neurogenic cough.

  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?

  Immediately post-intervention

• Patient comfort measures during ultrasound-guided injection of the internal branch of superior laryngeal nerve for neurogenic cough.

  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

  Day 1

• Time to complete superior laryngeal nerve injection under ultrasound.

  The amount of time will be recorded in minutes.

  Day 1

• Images and descriptors of internal branch of superior laryngeal nerve anatomy and normal variation.

  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.

  Day 1

• Change in volume of injectate in injection laryngoplasty measured by ultrasound compared to amount injected after procedure and at follow-up.

  The volume will be recorded in mL.

  Immediately post-intervention and at 4 week follow-up visit

• Presence, bulk, and function of tongue, suprahyoid, and infrahyoid musculature on ultrasound for patients with and without swallowing complaints.

  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.

  Day 1

• Evaluation of suprahyoid musculature on ultrasound for patients with muscle tension dysphonia.

  This is a qualitative outcome measure. Providers will provide a description of the suprahyoid musculature on ultrasound for patients with muscle tension dysphonia.

  Day 1

Study Arms (6)

Cough

EXPERIMENTAL

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.

Diagnostic Test: Ultrasound for cough

Vocal Cord Atrophy

EXPERIMENTAL

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.

Diagnostic Test: Ultrasound for vocal fold atrophy or vocal fold paresis/paralysis

Vocal Cord Paresis

EXPERIMENTAL

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.

Diagnostic Test: Ultrasound for vocal fold atrophy or vocal fold paresis/paralysis

Vocal Cord Paralysis

EXPERIMENTAL

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.

Diagnostic Test: Ultrasound for vocal fold atrophy or vocal fold paresis/paralysis

Dysphagia

EXPERIMENTAL

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.

Diagnostic Test: Ultrasound for dysphagia

Dysphonia

EXPERIMENTAL

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.

Diagnostic Test: Ultrasound for dysphonia

Interventions

Ultrasound for vocal fold atrophy or vocal fold paresis/paralysis DIAGNOSTIC_TEST

Adult patients who are seen at the Sean Parker Institute for the Voice and are determined to have vocal fold atrophy or vocal fold paresis/paralysis for whom injection laryngoplasty is recommended will undergo laryngeal ultrasound prior to the procedure to assess baseline anatomy as well as following the procedure (both immediately following the procedure as well as at follow-up visits) in order to assess the amount of injectate.

Vocal Cord Atrophy; Vocal Cord Paralysis; Vocal Cord Paresis

Ultrasound for dysphonia DIAGNOSTIC_TEST

Adult patients who are seen at the Sean Parker Institute for the Voice and are determined to have muscle tension dysphonia will undergo ultrasonography during their visit with laryngology or speech language pathology.

Dysphonia

Ultrasound for cough DIAGNOSTIC_TEST

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. Patients will be assessed for their comfort with undergoing the procedure and clinicians will be surveyed on the ease and benefit of performing the procedure under ultrasound guidance.

Cough

Ultrasound for dysphagia DIAGNOSTIC_TEST

Patients with and without swallowing complaints will be enrolled to assess their tongue, suprahyoid and infrahyoid musculature, including muscle identification, bulk and function.

Dysphagia

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age under 18 years and over 99 years
• Open neck wound including tracheostomy

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Cough; Vocal Cord Paralysis; Deglutition Disorders; Dysphonia

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Laryngeal Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Voice Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Anaïs Rameau, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Li, BS

CONTACT

(646) 962-7464; all4034@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 30, 2024
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)