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Completed

NCT Number: NCT04586855

Ultrasound Imaging of the Larynx and Diaphragm During NIV and Cough Assist

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Haukeland University Hospital

Bergen, Vestlandet, 5021, Norway

About this study

Transnasal fiberoptic laryngoscopy (TFL) is gold standard for visualising the larynx. TFL has been used to visualize the laryngeal response patterns during non-invasive therapeutic interventions, as during Mechanically Assisted Cough in patients with Amyotrophic Lateral Sclerosis. The examinations revealed that the larynx adducted during the application of positive pressures, which restricted the airflow and reduced the efficacy of the treatment. The higher treatment pressures resulted in ineffective interventions as a result of the adducted vocal cords obstructing flow. This knowledge has changed the treatment approach for patients with possible upper airway instability by individualizing the treatment pressures and flow due to laryngeal responses.

TFL may cause slight discomfort when placing the laryngoscope. Diagnostic ultrasound is non-invasive easily applicable technique that has gained increasing popularity in diagnosing cardiopulmonary and laryngeal conditions during the recent times. The aim of the study is to investigate whether the diagnostic ultrasound of the larynx can be as accurate as TFL during Mechanically Assisted Cough and Non-Invasive Ventilation (NIV). The present study will include healthy participants. Hypothesis is that diagnostic ultrasound of larynx can provide clinical valuable information of the laryngeal response patterns during Mechanically Assisted Cough and NIV.

The aims of the study are:

  • To evaluate the feasibility of diagnostic ultrasound imaging of the larynx, and to compare to the gold standard of TFL used during ongoing NIV and Mechanically Assisted Cough in healthy subjects.
  • To evaluate the feasibility of ultrasound imaging if the diaphragm during ongoing NIV and Mechanically Assisted Cough in healthy subjects.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy subjects

Exclusion criteria

  • history of laryngospasm or pneumothorax

Treatment and study plan

Diagnostic Ultrasound

Diagnostic Test

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

Transnasal Fiberoptic Laryngoscopy

Diagnostic Test

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

Primary outcomes

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

    Time frame: Day 1

    Number of participants.

  2. Obstructive movements in larynx on TFL during inspiration

    Time frame: Day 1

    Number of participants.

  3. Closure in larynx on TFL during the compression phase of cough

    Time frame: Day 1

    Number of participants.

  4. Opening movements in larynx on TFL during expiration

    Time frame: Day 1

    Number of participants.

  5. Narrower movements in larynx on TFL during expiration

    Time frame: Day 1

    Number of participants.

  6. Obstructive movements in larynx on TFL during expiration

    Time frame: Day 1

    Number of participants.

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

    Time frame: Day 1

    Number of participants.

  8. Obstructive movements in larynx on USA during inspiration

    Time frame: Day 1

    Number of participants.

  9. Closure in larynx on USA during the compression phase of cough

    Time frame: Day 1

    Number of participants.

  10. Opening movements in larynx on USA during expiration

    Time frame: Day 1

    Number of participants.

  11. Narrower movements in larynx on USA during expiration

    Time frame: Day 1

    Number of participants.

  12. Obstructive movements in larynx on USA during expiration

    Time frame: Day 1

    Number of participants.

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

    Time frame: Day 1

    Number of participants.

  14. Obstructive movements in larynx on USL during inspiration

    Time frame: Day 1

    Number of participants.

  15. Closure in larynx on USL during the compression phase of cough

    Time frame: Day 1

    Number of participants.

  16. Opening movements in larynx on USL during expiration

    Time frame: Day 1

    Number of participants.

  17. Narrower movements in larynx on USL during expiration

    Time frame: Day 1

    Number of participants.

  18. Obstructive movements in larynx on USL during expiration

    Time frame: Day 1

    Number of participants.

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

    Time frame: Day 1

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

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

    Time frame: Day 1

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

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

    Time frame: Day 1

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

  22. Ultrasound imaging of diaphragm excursion

    Time frame: Day 1

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

Secondary outcomes

  1. Subjects perception of the examination with TFL - VAS scale

    Time frame: Day 1

    Participant's experience of the examination will be evaluated on a Visual Analog Scale (VAS) from 0-10 where higher number indicate more discomfort.

  2. Subjects perception of the examination with Laryngeal ultrasound - VAS scale

    Time frame: Day 1

    Participant's experience of the examination will be evaluated on a Visual Analog Scale (VAS) from 0-10 where higher number indicate more discomfort.

  3. Airflow registration

    Time frame: Day 1

    A pneumotachograph inserted in the Circuit between the facemask and the therapeutic device will register airflow during the interventions. Interruptions of the airflow will verify the possible laryngeal adductions.

  4. Pressure registration

    Time frame: Day 1

    A pressure transducer inserted in the Circuit between the facemask and the therapeutic device measures the pressure and verify the settings of the NIV and Mechanically assisted Cough.

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • Sorlandet Hospital HF
  • St Vincent's Hospital, Sydney

Registry information

Official study title

Can Ultrasound Imaging of Both Upper Airways and Diaphragm be Used to Guide Efficacy on Non-invasive Ventilation and Cough Assist

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 14, 2020
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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