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

NCT05686941 | Recruiting

• 1 other identifier: 298631
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Inducible laryngeal obstruction; Ultrasound

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Healthy Volunteers

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

Other: Trans-cutaneous Laryngeal ultrasound (TLUS)

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); Other: TLUS and simultaneous laryngoscopy

Interventions

Trans-cutaneous Laryngeal ultrasound (TLUS) OTHER

Assessment of the larynx (specifically the vocal cords) with hand held portable ultrasound device to assess the movements of the vocal cords

Healthy Volunteers; Patients with suspected Inducible laryngeal Obstruction (ILO)

TLUS and simultaneous laryngoscopy OTHER

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)

Also known as: TLUS

Patients with suspected Inducible laryngeal Obstruction (ILO)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lancashire Teaching Hospitals NHS Foundation Trust: lead
• Edge Hill University: collaborator
• University College, London: collaborator
• Lancaster University: collaborator
• University of Central Lancashire: collaborator

Study Sites (1)

Lancashire Teaching Hospitals NHS Trust

Preston, Lancashire, PR2 9HT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Vocal Cord Dysfunction

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases

Study Officials

• Kina Bennett

  Lancashire Teaching Hospitals NHS Trust

  STUDY CHAIR

• Claire Slinger

  Lancashire Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire Slinger

CONTACT

01171523237; claire.slinger@lthtr.nhs.uk

Kina Bennett

CONTACT

kina.bennett@lthtr.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Speech & Language Therapist

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: January 17, 2023
• Study Start: August 24, 2022
• Primary Completion: June 27, 2025
• Study Completion: June 27, 2025
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)