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NCT Number: NCT06579989

Usefulness and Feasibility of Ultrasound in Office Laryngology Procedures

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.

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Key information

Conditions

Cough Cranial Nerve Diseases Deglutition Disorders Digestive System Diseases Dysphagia Dysphonia Esophageal Diseases Gastrointestinal Diseases Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Paralysis Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Vagus Nerve Diseases Vocal Cord Atrophy Vocal Cord Paralysis Vocal Cord Paresis Voice Disorders

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

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

    Time frame: 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).

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

    Time frame: 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?

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

    Time frame: 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

  4. Time to complete superior laryngeal nerve injection under ultrasound.

    Time frame: Day 1

    The amount of time will be recorded in minutes.

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

    Time frame: 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.

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

    Time frame: Immediately post-intervention and at 4 week follow-up visit

    The volume will be recorded in mL.

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

    Time frame: 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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Joclin Rabinovich, BS

CONTACT

[email protected]

(646) 962-7464 ext. 19882

John Ramos, BA

CONTACT

[email protected]

(646) 962-7464 ext. 19882

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

Usefulness and Feasibility of Ultrasound in Office Laryngology Procedures: A Pilot Study

Important dates

Study start
2027
Primary completion
2029
Study completion
2030
First posted
Aug 30, 2024
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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