Usefulness and Feasibility of Ultrasound in Office Laryngology Procedures
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorWeill Medical College of Cornell University
About this trial
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
This trial accepts healthy volunteersQualifiers
Age over 18 years
Recommended to undergo superior laryngeal nerve block
US-Assessment of Superior Laryngeal Nerve Anatomy
Age over 18 years
Disqualifiers
Age under 18 years and over 99 years
Open neck wound including tracheostomy
Trial design
Design model
Parallel
Treatments tested in this trial
Ultrasound for cough
Diagnostic testAdult 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 testAdult 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 testPatients 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 testAdult 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.
Treatment groups
200 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: CoughExperimental treatment 1 intervention
Group B: Vocal Cord AtrophyExperimental treatment 1 intervention
Group C: Vocal Cord ParesisExperimental treatment 1 intervention
Group D: Vocal Cord ParalysisExperimental treatment 1 intervention
Group E: DysphagiaExperimental treatment 1 intervention
Group F: DysphoniaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Quantitative clinician-reported usability measure of ultrasound during injection of the internal branch of superior laryngeal nerve for neurogenic cough.
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).
Time frame
Immediately post-intervention2
Qualitative clinician-reported usability measure of ultrasound during injection of the internal branch of superior laryngeal nerve for neurogenic cough.
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?
Time frame
Immediately post-intervention3
Patient comfort measures during ultrasound-guided injection of the internal branch of superior laryngeal nerve for neurogenic cough.
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 frame
Day 14
Time to complete superior laryngeal nerve injection under ultrasound.
The amount of time will be recorded in minutes.
Time frame
Day 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: