Clinical Trials Directory

Trials / Unknown

UnknownNCT05686941

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
Unknown
Phase
Study type
Observational
Enrollment
60 (estimated)
Sponsor
Lancashire Teaching Hospitals NHS Foundation Trust · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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

Conditions

Interventions

TypeNameDescription
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 laryngoscopyAssessment 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)

Timeline

Start date
2022-08-24
Primary completion
2025-06-27
Completion
2025-06-27
First posted
2023-01-17
Last updated
2024-02-22

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT05686941. Inclusion in this directory is not an endorsement.