Is Laryngeal Ultrasound Useful in the Assessment for ILO? A Protocol for a Two-stage Exploratory Pilot Study

Is Laryngeal Ultrasound a Useful Tool in the Assessment of Inducible Laryngeal Obstruction? A Protocol for a Two-stage Exploratory Pilot Study

This study is a feasibility study to see if an ultrasound scan of the vocal cords can detect narrowing of the vocal cords as seen in a condition called inducible laryngeal Obstruction (the vocal cords narrow or close on breathing in, which makes it very difficult to breathe).

Study Overview

• Status: Recruiting
• Conditions: Vocal Cord Dysfunction; Asthma Brittle; Inducible Laryngeal Obstruction; Paradoxical Vocal Fold Motion
• Intervention / Treatment: Other: Trans-cutaneous Laryngeal ultrasound (TLUS); Other: TLUS and simultaneous laryngoscopy

Detailed Description

This study aims to help understand whether viewing the vocal cords with an ultrasound device is useful to detect the movement of the vocal cords during breathing. This study is useful, as some people who have abnormal movements of the vocal cords on breathing in find it more difficult to breathe in, and often this leads to a big impact on their quality of life. It may also mean they are on medications that they may not need not be on, as abnormal movements of the vocal cords can often be mistaken for asthma, so they may have been placed on asthma medication when they may not need to be.

Usually, the way the abnormal movements of the vocal cords are seen now is via a small camera is placed via the nose into the throat to directly look at the vocal cords. Some people find this uncomfortable and may have to wait for a long time for it to happen. Also, this procedure is expensive, and is done in an endoscopy theatre, which may make it more daunting for some people, and make the wait longer. There are only a few centres that do these assessments with the camera, so people may have to travel some distance to have an assessment.

It is hoped, by doing this study, the investigators can see whether ultrasound can help assess if people have abnormal vocal cord movements when they breathe in. This will be done in 2 stages, one with healthy volunteers, and the second stage in patients who have been referred for assessment of their vocal cords to see if they have abnormal movements when breathing in. The investigators will also ask the volunteers and patients what their experience of having the ultrasound was like, and will ask the patients in the study how the ultrasound scan felt, when compared to the camera test

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Claire Slinger; Phone Number: 01171523237; Email: claire.slinger@lthtr.nhs.uk
• Study Contact Backup: Name: Kina Bennett; Email: kina.bennett@lthtr.nhs.uk

Study Locations

• United Kingdom
  • Lancashire
    • Preston, Lancashire, United Kingdom, PR2 9HT
      • Recruiting
      • Lancashire Teaching Hospitals NHS Trust
      • Contact: Kina Bennett; Email: kina.bennett@lthtr.nhs.uk
      • Principal Investigator: Claire Slinger

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

• No definite signs or symptoms of vocal fold paralysis
• No of history laryngeal surgeries
• No history of pathology pathology
• Too anxious to undergo procedure

Description

Inclusion Criteria:

Healthy volunteers:

• No definite signs or symptoms of vocal fold paralysis
• No voice change
• No history laryngeal surgeries
• No History of pathology
• No uncontrolled Respiratory disease

Exclusion Criteria:

• Participants with a known vocal fold pathology
• Participants with a history of head and neck surgery.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Volunteers; Employees of the Host organisation in the Respiratory Team who meet the inclusion criteria	Other: Trans-cutaneous Laryngeal ultrasound (TLUS); Assessment of the larynx (specifically the vocal cords) with hand held portable ultrasound device to assess the movements of the vocal cords
Patients with suspected Inducible laryngeal Obstruction (ILO); Patients referred to a Tertiary referral centre who are suspected of having ILO	Other: Trans-cutaneous Laryngeal ultrasound (TLUS); Assessment of the larynx (specifically the vocal cords) with hand held portable ultrasound device to assess the movements of the vocal cords; Other: TLUS and simultaneous laryngoscopy; Assessment of the larynx (specifically the vocal cords) with hand held portable ultrasound device to assess the movements of the vocal cords with simultaneous video laryngoscopy (usual care); Other Names: TLUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of vocal cords that are seen with the ultrasound	Can the vocal cord be seen under TLUS for Healthy Volunteers? Numeric data.	1 day
Number of particpants where visualisation of mimicked inspiratory adduction is visible on ultrasound	Can the vocal cords be seen to adduct under TLUS when healthy volunteers mimic ILO? Binary outcome: yes or no.	1 day
To assess the sensitivity, specificity and positive predictive value of the use of ultrasound	To assess the sensitivity, specificity and positive predictive value of the use of ultrasound in the assessment of ILO, using Laryngoscopy as reference standard in the patient population (n=30)	1 day
Questionnaire Investigating user perspectives on the acceptability of TLUS	A qualitative questionnaire investigating the patient and healthy volunteer perspectives on their experiences of undergoing TLUS assessment of the vocal cords. The questionnaire will look at the acceptability of the assessment in terms of comfort, repeatability, and comparison with laryngoscopy (for patients only).	1 day

Collaborators and Investigators

• Sponsor: Lancashire Teaching Hospitals NHS Foundation Trust
• Collaborators: University of Central Lancashire; University College, London; Edge Hill University; Lancaster University
• Investigators: Study Chair: Kina Bennett, Lancashire Teaching Hospitals NHS Trust; Principal Investigator: Claire Slinger, Lancashire Teaching Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2022
• Primary Completion (Estimated): June 27, 2025
• Study Completion (Estimated): June 27, 2025

Study Registration Dates

• First Submitted: December 16, 2022
• First Submitted That Met QC Criteria: January 13, 2023
• First Posted (Actual): January 17, 2023

Study Record Updates

• Last Update Posted (Actual): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Ultrasound; Inducible laryngeal obstruction
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Laryngeal Diseases; Vocal Cord Dysfunction
• Other Study ID Numbers: 298631

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No