NCT04586855

Brief Summary

The study examines if diagnostic ultrasound imaging of larynx and diaphragm can be as accurate as transnasal fiberoptic laryngoscopy in visualizing the larynx during NIV and Mechanically Assisted Cough interventions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2022

Completed
Last Updated

March 24, 2025

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

July 27, 2020

Last Update Submit

March 19, 2025

Conditions

Healthy Persons

Keywords

Transnasal Fiberoptic LaryngoscopyDiagnostic UltrasoundCough AssistNoninvasive ventilation

Outcome Measures

Primary Outcomes (22)

  • Opening movements in larynx on transnasal fiberoptic laryngoscopy (TFL) during inspiration

    Number of participants.

    Day 1

  • Obstructive movements in larynx on TFL during inspiration

    Number of participants.

    Day 1

  • Closure in larynx on TFL during the compression phase of cough

    Number of participants.

    Day 1

  • Opening movements in larynx on TFL during expiration

    Number of participants.

    Day 1

  • Narrower movements in larynx on TFL during expiration

    Number of participants.

    Day 1

  • Obstructive movements in larynx on TFL during expiration

    Number of participants.

    Day 1

  • Opening movements in larynx on Anterior Ultrasound (USA) during inspiration

    Number of participants.

    Day 1

  • Obstructive movements in larynx on USA during inspiration

    Number of participants.

    Day 1

  • Closure in larynx on USA during the compression phase of cough

    Number of participants.

    Day 1

  • Opening movements in larynx on USA during expiration

    Number of participants.

    Day 1

  • Narrower movements in larynx on USA during expiration

    Number of participants.

    Day 1

  • Obstructive movements in larynx on USA during expiration

    Number of participants.

    Day 1

  • Opening movements in larynx on Lateral Ultrasound (USL) during inspiration

    Number of participants.

    Day 1

  • Obstructive movements in larynx on USL during inspiration

    Number of participants.

    Day 1

  • Closure in larynx on USL during the compression phase of cough

    Number of participants.

    Day 1

  • Opening movements in larynx on USL during expiration

    Number of participants.

    Day 1

  • Narrower movements in larynx on USL during expiration

    Number of participants.

    Day 1

  • Obstructive movements in larynx on USL during expiration

    Number of participants.

    Day 1

  • Comparison of observed movements in the larynx on transnasal fiberoptic laryngoscopy (TFL) and Anterior Ultrasound (USA) imaging.

    The chi-square test will assess differences between examination methods.

    Day 1

  • Comparison of observed movements in the larynx on transnasal fiberoptic laryngoscopy (TFL) and Lateral Ultrasound (USL) imaging.

    The chi-square test will assess differences between examination methods.

    Day 1

  • Comparison of observed movements in the larynx on Anterior Ultrasound (USA) and Lateral Ultrasound (USL) imaging.

    The chi-square test will assess differences between examination methods.

    Day 1

  • Ultrasound imaging of diaphragm excursion

    Measurements will be performed in quiet breathing, NIV and Cough Assist. Diaphragm excursions are recorded in M-mode, and will be presented in millimeters.

    Day 1

Secondary Outcomes (4)

  • Subjects perception of the examination with TFL - VAS scale

    Day 1

  • Subjects perception of the examination with Laryngeal ultrasound - VAS scale

    Day 1

  • Airflow registration

    Day 1

  • Pressure registration

    Day 1

Study Arms (1)

Healthy persons

Noninvasive ventilation and Cough Assist

Diagnostic Test: Diagnostic UltrasoundDiagnostic Test: Transnasal Fiberoptic Laryngoscopy

Interventions

Diagnostic UltrasoundDIAGNOSTIC_TEST

To investigate if Ultrasound imaging can visualize the larynx during NIV and Cough Assist, and be as accurate as laryngoscopy

Healthy persons
Transnasal Fiberoptic LaryngoscopyDIAGNOSTIC_TEST

To investigate if Ultrasound imaging can visualize the larynx during NIV and Cough Assist, and be as accurate as laryngoscopy

Healthy persons

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers will be recruited among Healthcare Professionals and medical- and physiotherapy students

You may qualify if:

  • Healthy subjects

You may not qualify if:

  • history of laryngospasm or pneumothorax

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, Vestlandet, 5021, Norway

Location

Related Publications (4)

  • Fernald PS, Linden JD. The human content response in the Holtzman Inkblot Technique. J Proj Tech Pers Assess. 1966 Oct;30(5):441-6. No abstract available.

    PMID: 5339574BACKGROUND

  • Andersen TM, Sandnes A, Fondenes O, Nilsen RM, Tysnes OB, Heimdal JH, Clemm HH, Halvorsen T, Vollsaeter M, Roksund OD. Laryngeal Responses to Mechanically Assisted Cough in Progressing Amyotrophic Lateral Sclerosis. Respir Care. 2018 May;63(5):538-549. doi: 10.4187/respcare.05924. Epub 2018 Apr 17.

    PMID: 29666294BACKGROUND

  • Brekka AK, Ntoumenopoulos G, Roksund OD, Engeset MS, Clemm H, Halvorsen T, Vollsaeter M, Andersen T. Use of Laryngeal Ultrasound to Observe Laryngeal Movements During Noninvasive Ventilation in Healthy Volunteers. Respir Care. 2025 Mar;70(3):249-257. doi: 10.4187/respcare.12201. Epub 2024 Oct 29.

    PMID: 39472069BACKGROUND

  • Brekka AK, Vollsaeter M, Ntoumenopoulos G, Clemm HH, Halvorsen T, Roksund OD, Andersen TM. Adjustments of non-invasive ventilation and mechanically assisted cough by combining ultrasound imaging of the larynx with transnasal fibre-optic laryngoscopy: a protocol for an experimental study. BMJ Open. 2022 May 25;12(5):e059234. doi: 10.1136/bmjopen-2021-059234.

    PMID: 35613803BACKGROUND

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Tiina M Andersen, PhD

    Haukeland University Hospital

    PRINCIPAL INVESTIGATOR

  • George Ntoumenopoulos, PhD

    St Vincent's Hospital, Sydney

    STUDY CHAIR

  • Maria Vollsæter, PhD

    Haukeland University Hospital

    STUDY CHAIR

  • Anne Kristine Brekka, MSc

    Sorlandet Hospital HF

    STUDY CHAIR

  • Ola D Røksund, Professor

    Bergen University College

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2020

First Posted

October 14, 2020

Study Start

January 1, 2022

Primary Completion

April 7, 2022

Study Completion

April 7, 2022

Last Updated

March 24, 2025

Record last verified: 2021-07

Locations

NO(1)