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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05686941
Enrollment
60
Registered
2023-01-17
Start date
2022-08-24
Completion date
2025-06-27
Last updated
2024-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma Brittle, Inducible Laryngeal Obstruction, Paradoxical Vocal Fold Motion, Vocal Cord Dysfunction

Keywords

Inducible laryngeal obstruction, Ultrasound

Brief summary

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).

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

Interventions

OTHERTrans-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

OTHERTLUS 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)

Sponsors

Edge Hill University
CollaboratorOTHER
University College, London
CollaboratorOTHER
Lancaster University
CollaboratorOTHER
University of Central Lancashire
CollaboratorOTHER
Lancashire Teaching Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of vocal cords that are seen with the ultrasound1 dayCan the vocal cord be seen under TLUS for Healthy Volunteers? Numeric data.
Number of particpants where visualisation of mimicked inspiratory adduction is visible on ultrasound1 dayCan the vocal cords be seen to adduct under TLUS when healthy volunteers mimic ILO? Binary outcome: yes or no.
To assess the sensitivity, specificity and positive predictive value of the use of ultrasound1 dayTo 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)
Questionnaire Investigating user perspectives on the acceptability of TLUS1 dayA 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).

Countries

United Kingdom

Contacts

Primary ContactClaire Slinger
claire.slinger@lthtr.nhs.uk01171523237
Backup ContactKina Bennett
kina.bennett@lthtr.nhs.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026