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

Lancashire Teaching Hospitals NHS Foundation Trust

Status: Enrolling

Conditions: Paradoxical Vocal Fold Motion; Inducible Laryngeal Obstruction; Vocal Cord Dysfunction; Asthma Brittle

Treatments: Other: Trans-cutaneous Laryngeal ultrasound (TLUS); Other: TLUS and simultaneous laryngoscopy

Study type: Observational

Funder types: Other

Identifiers

NCT05686941

298631

Details and patient eligibility

About

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).

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

Healthy Volunteers

Description:

Employees of the Host organisation in the Respiratory Team who meet the inclusion criteria

Treatment:

Other: Trans-cutaneous Laryngeal ultrasound (TLUS)

Patients with suspected Inducible laryngeal Obstruction (ILO)

Description:

Patients referred to a Tertiary referral centre who are suspected of having ILO

Treatment:

Other: Trans-cutaneous Laryngeal ultrasound (TLUS)

Other: TLUS and simultaneous laryngoscopy