Clinical trial NCT06579989: Usefulness and Feasibility of Ultrasound in Office Laryngology Procedures
Official title: Usefulness and Feasibility of Ultrasound in Office Laryngology Procedures: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cough
Vocal Cord Atrophy
Vocal Cord Paresis
Vocal Cord Paralysis
Dysphagia
Dysphonia
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Quantitative clinician-reported usability measure of ultrasound during injection of the internal branch of superior laryngeal nerve for neurogenic cough.
timeFrame: Immediately post-intervention
measure: Qualitative clinician-reported usability measure of ultrasound during injection of the internal branch of superior laryngeal nerve for neurogenic cough.
timeFrame: Immediately post-intervention
measure: Patient comfort measures during ultrasound-guided injection of the internal branch of superior laryngeal nerve for neurogenic cough.
timeFrame: Day 1
measure: Time to complete superior laryngeal nerve injection under ultrasound.
timeFrame: Day 1
measure: Images and descriptors of internal branch of superior laryngeal nerve anatomy and normal variation.
timeFrame: Day 1
measure: Change in volume of injectate in injection laryngoplasty measured by ultrasound compared to amount injected after procedure and at follow-up.
timeFrame: Immediately post-intervention and at 4 week follow-up visit
measure: Presence, bulk, and function of tongue, suprahyoid, and infrahyoid musculature on ultrasound for patients with and without swallowing complaints.
timeFrame: Day 1
measure: Evaluation of suprahyoid musculature on ultrasound for patients with muscle tension dysphonia.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Anaïs Rameau, MD
role: PRINCIPAL_INVESTIGATOR
References: