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Usefulness and Feasibility of Ultrasound in Office Laryngology Procedures

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06579989
Enrollment
200
Registered
2024-08-30
Start date
2027-01-01
Completion date
2030-01-01
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIAGNOSTIC_TESTUltrasound for dysphagia

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

DIAGNOSTIC_TESTUltrasound for dysphonia

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.

DIAGNOSTIC_TESTUltrasound 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. 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.

DIAGNOSTIC_TESTUltrasound for vocal fold atrophy or vocal fold paresis/paralysis

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.

Sponsors

Weill Medical College of Cornell University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Quantitative clinician-reported usability measure of ultrasound during injection of the internal branch of superior laryngeal nerve for neurogenic cough.Immediately post-interventionThe 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-interventionThe 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 1Number 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 1The amount of time will be recorded in minutes.
Images and descriptors of internal branch of superior laryngeal nerve anatomy and normal variation.Day 1This 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 visitThe 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 1This 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 1This is a qualitative outcome measure. Providers will provide a description of the suprahyoid musculature on ultrasound for patients with muscle tension dysphonia.

Countries

United States

Contacts

CONTACTJohn Ramos, BA
jmr4003@med.cornell.edu(646) 962-7464
CONTACTJoclin Rabinovich, BS
jor4039@med.cornell.edu(646) 962-7464
PRINCIPAL_INVESTIGATORAnaïs Rameau, MD

Weill Medical College of Cornell University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026