Not yet recruiting NCT06579989
Usefulness and Feasibility of Ultrasound in Office Laryngology Procedures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasound for cough, Ultrasound for vocal fold atrophy or vocal fold paresis/paralysis, Ultrasound for dysphagia, Ultrasound for dysphonia.
- Who it may be relevant to
- Registry conditions: Cough, Vocal Cord Atrophy, Vocal Cord Paresis, Vocal Cord Paralysis. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Usefulness and Feasibility of Ultrasound in Office Laryngology Procedures: A Pilot Study
Overview
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 test 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. Patients will be assessed for their comfort with undergoing the procedure and clinicians will be surveyed on the ease and benefit of performing th - Diagnostic test Ultrasound 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. - Diagnostic test Ultrasound 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 test Ultrasound 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.
Primary outcome measures
- 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]
- 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]
- Patient comfort measures during ultrasound-guided injection of the internal branch of superior laryngeal nerve for neurogenic cough. [Time frame: Day 1]
- Time to complete superior laryngeal nerve injection under ultrasound. [Time frame: Day 1]
- Images and descriptors of internal branch of superior laryngeal nerve anatomy and normal variation. [Time frame: Day 1]
- 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]
- Presence, bulk, and function of tongue, suprahyoid, and infrahyoid musculature on ultrasound for patients with and without swallowing complaints. [Time frame: Day 1]
- Evaluation of suprahyoid musculature on ultrasound for patients with muscle tension dysphonia. [Time frame: Day 1]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Weill Cornell Medicine — New York
Identifiers
NCT: NCT06579989 · 23-10026663