Clinical trial NCT05686941: Is Laryngeal Ultrasound Useful in the Assessment for ILO? A Protocol for a Two-stage Exploratory Pilot Study
Official title: Is Laryngeal Ultrasound a Useful Tool in the Assessment of Inducible Laryngeal Obstruction? A Protocol for a Two-stage Exploratory Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vocal Cord Dysfunction
Asthma Brittle
Inducible Laryngeal Obstruction
Paradoxical Vocal Fold Motion
Keywords: Inducible laryngeal obstruction
Ultrasound
Lead sponsor: Lancashire Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Edge Hill University
name: University College, London
name: Lancaster University
name: University of Central Lancashire
First posted: 2023-01-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of vocal cords that are seen with the ultrasound
timeFrame: 1 day
measure: Number of particpants where visualisation of mimicked inspiratory adduction is visible on ultrasound
timeFrame: 1 day
measure: To assess the sensitivity, specificity and positive predictive value of the use of ultrasound
timeFrame: 1 day
measure: Questionnaire Investigating user perspectives on the acceptability of TLUS
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Preston
country: United Kingdom
facility: Lancashire Teaching Hospitals NHS Trust
state: Lancashire
Study officials:
affiliation: Lancashire Teaching Hospitals NHS Trust
name: Kina Bennett
role: STUDY_CHAIR
affiliation: Lancashire Teaching Hospitals NHS Trust
name: Claire Slinger
role: PRINCIPAL_INVESTIGATOR
References: