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| Name | Class |
|---|---|
| St Vincent's Hospital, Sydney | OTHER |
| Sorlandet Hospital HF | OTHER_GOV |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy persons | Noninvasive ventilation and Cough Assist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic Ultrasound | Diagnostic Test | To investigate if Ultrasound imaging can visualize the larynx during NIV and Cough Assist, and be as accurate as laryngoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects perception of the examination with TFL - VAS scale | Participant's experience of the examination will be evaluated on a Visual Analog Scale (VAS) from 0-10 where higher number indicate more discomfort. | Day 1 |
| Subjects perception of the examination with Laryngeal ultrasound - VAS scale |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy volunteers will be recruited among Healthcare Professionals and medical- and physiotherapy students
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Bergen | Vestlandet | 5021 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27174631 | Background | 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. | |
| 29666294 |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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 |
|
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 |
Participant's experience of the examination will be evaluated on a Visual Analog Scale (VAS) from 0-10 where higher number indicate more discomfort. |
| Day 1 |
| Airflow registration | 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. | Day 1 |
| Pressure registration | 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. | Day 1 |
| 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. |
| 35613803 | Background | 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. |
| 39472069 | Result | 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. |