Usefulness and Feasibility of Ultrasound in Office Laryngology Procedures

NCT06579989 — Not applicable, Not yet recruiting, 200 participants, Weill Medical College of Cornell University

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

RegistryNCT06579989
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; non randomized, parallel, masking: none, diagnostic
Enrollment200 (Estimated)
SponsorWeill Medical College of Cornell University (Other)
ConditionsCough, Vocal Cord Atrophy, Vocal Cord Paresis, Vocal Cord Paralysis, Dysphagia, Dysphonia
InterventionsUltrasound for cough, Ultrasound for vocal fold atrophy or vocal fold paresis/paralysis, Ultrasound for dysphagia, Ultrasound for dysphonia (Diagnostic test)
Datesstart 2027-01-01 (estimated), primary completion 2029-01-01 (estimated), completion 2030-01-01 (estimated), first posted 2024-08-30, last updated 2026-06-16
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Cough All trials for Vocal Cord Atrophy All trials of Ultrasound for cough All trials of Ultrasound for vocal fold atrophy or vocal fold paresis/paralysis

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
CoughExperimentalDiagnostic Test: Ultrasound for coughAdult 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 AtrophyExperimentalDiagnostic Test: Ultrasound for vocal fold atrophy or vocal fold paresis/paralysisAdult 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 ParesisExperimentalDiagnostic Test: Ultrasound for vocal fold atrophy or vocal fold paresis/paralysisAdult 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 ParalysisExperimentalDiagnostic Test: Ultrasound for vocal fold atrophy or vocal fold paresis/paralysisAdult 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.
DysphagiaExperimentalDiagnostic Test: Ultrasound for dysphagiaAdult 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.
DysphoniaExperimentalDiagnostic Test: Ultrasound for dysphoniaAdult 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.
  • 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.

+Outcome measures

Primary outcomes

  • 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.

+Eligibility

Sex: All, ages: 18 Years to 99 Years, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
Weill Cornell MedicineNew York, New YorkUnited States

+Investigators

  • Anaïs Rameau, MD, Principal investigator, Weill Medical College of Cornell University