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

Overview

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.

Full Title of Study: “Can Ultrasound Imaging of Both Upper Airways and Diaphragm be Used to Guide Efficacy on Non-invasive Ventilation and Cough Assist”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: April 7, 2022

Detailed Description

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.

Interventions

  • Diagnostic Test: Diagnostic Ultrasound
    • To investigate if Ultrasound imaging can visualize the larynx during NIV and Cough Assist, and be as accurate as laryngoscopy
  • Diagnostic Test: Transnasal Fiberoptic Laryngoscopy
    • To investigate if Ultrasound imaging can visualize the larynx during NIV and Cough Assist, and be as accurate as laryngoscopy

Arms, Groups and Cohorts

  • Healthy persons
    • Noninvasive ventilation and Cough Assist

Clinical Trial Outcome Measures

Primary Measures

  • Opening movements in larynx on transnasal fiberoptic laryngoscopy (TFL) during inspiration
    • Time Frame: Day 1
    • Number of participants.
  • Obstructive movements in larynx on TFL during inspiration
    • Time Frame: Day 1
    • Number of participants.
  • Closure in larynx on TFL during the compression phase of cough
    • Time Frame: Day 1
    • Number of participants.
  • Opening movements in larynx on TFL during expiration
    • Time Frame: Day 1
    • Number of participants.
  • Narrower movements in larynx on TFL during expiration
    • Time Frame: Day 1
    • Number of participants.
  • Obstructive movements in larynx on TFL during expiration
    • Time Frame: Day 1
    • Number of participants.
  • Opening movements in larynx on Anterior Ultrasound (USA) during inspiration
    • Time Frame: Day 1
    • Number of participants.
  • Obstructive movements in larynx on USA during inspiration
    • Time Frame: Day 1
    • Number of participants.
  • Closure in larynx on USA during the compression phase of cough
    • Time Frame: Day 1
    • Number of participants.
  • Opening movements in larynx on USA during expiration
    • Time Frame: Day 1
    • Number of participants.
  • Narrower movements in larynx on USA during expiration
    • Time Frame: Day 1
    • Number of participants.
  • Obstructive movements in larynx on USA during expiration
    • Time Frame: Day 1
    • Number of participants.
  • Opening movements in larynx on Lateral Ultrasound (USL) during inspiration
    • Time Frame: Day 1
    • Number of participants.
  • Obstructive movements in larynx on USL during inspiration
    • Time Frame: Day 1
    • Number of participants.
  • Closure in larynx on USL during the compression phase of cough
    • Time Frame: Day 1
    • Number of participants.
  • Opening movements in larynx on USL during expiration
    • Time Frame: Day 1
    • Number of participants.
  • Narrower movements in larynx on USL during expiration
    • Time Frame: Day 1
    • Number of participants.
  • Obstructive movements in larynx on USL during expiration
    • Time Frame: Day 1
    • Number of participants.
  • 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.
  • 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.
  • 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.
  • 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 Measures

  • 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.
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy subjects Exclusion Criteria:

  • history of laryngospasm or pneumothorax

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Haukeland University Hospital
  • Collaborator
    • St Vincent’s Hospital, Sydney
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Tiina M Andersen, PhD, Principal Investigator, Haukeland University Hospital
    • George Ntoumenopoulos, PhD, Study Chair, St Vincent’s Hospital, Sydney
    • Maria Vollsæter, PhD, Study Chair, Haukeland University Hospital
    • Anne Kristine Brekka, MSc, Study Chair, Sorlandet Hospital HF
    • Ola D Røksund, Professor, Study Chair, Bergen University College

References

Andersen T, Sandnes A, Brekka AK, Hilland M, Clemm H, Fondenes O, Tysnes OB, Heimdal JH, Halvorsen T, Vollsaeter M, Roksund OD. Laryngeal response patterns influence the efficacy of mechanical assisted cough in amyotrophic lateral sclerosis. Thorax. 2017 Mar;72(3):221-229. doi: 10.1136/thoraxjnl-2015-207555. Epub 2016 May 12.

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.

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