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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04586855
Enrollment
30
Registered
2020-10-14
Start date
2022-01-01
Completion date
2022-04-07
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Persons

Keywords

Transnasal Fiberoptic Laryngoscopy, Diagnostic Ultrasound, Cough Assist, Noninvasive ventilation

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.

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_TESTDiagnostic Ultrasound

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

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

Sponsors

St Vincent's Hospital, Sydney
CollaboratorOTHER
Sorlandet Hospital HF
CollaboratorOTHER_GOV
Haukeland University Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Healthy subjects

Exclusion criteria

* history of laryngospasm or pneumothorax

Design outcomes

Primary

MeasureTime frameDescription
Ultrasound imaging of diaphragm excursionDay 1Measurements will be performed in quiet breathing, NIV and Cough Assist. Diaphragm excursions are recorded in M-mode, and will be presented in millimeters.
Opening movements in larynx on Lateral Ultrasound (USL) during inspirationDay 1Number of participants.
Obstructive movements in larynx on USL during inspirationDay 1Number of participants.
Closure in larynx on USL during the compression phase of coughDay 1Number of participants.
Comparison of observed movements in the larynx on transnasal fiberoptic laryngoscopy (TFL) and Anterior Ultrasound (USA) imaging.Day 1The 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.Day 1The 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.Day 1The chi-square test will assess differences between examination methods.
Obstructive movements in larynx on USA during expirationDay 1Number of participants.
Opening movements in larynx on USL during expirationDay 1Number of participants.
Narrower movements in larynx on USL during expirationDay 1Number of participants.
Obstructive movements in larynx on USL during expirationDay 1Number of participants.
Obstructive movements in larynx on TFL during inspirationDay 1Number of participants.
Closure in larynx on TFL during the compression phase of coughDay 1Number of participants.
Opening movements in larynx on TFL during expirationDay 1Number of participants.
Narrower movements in larynx on TFL during expirationDay 1Number of participants.
Obstructive movements in larynx on TFL during expirationDay 1Number of participants.
Opening movements in larynx on Anterior Ultrasound (USA) during inspirationDay 1Number of participants.
Obstructive movements in larynx on USA during inspirationDay 1Number of participants.
Closure in larynx on USA during the compression phase of coughDay 1Number of participants.
Opening movements in larynx on USA during expirationDay 1Number of participants.
Narrower movements in larynx on USA during expirationDay 1Number of participants.
Opening movements in larynx on transnasal fiberoptic laryngoscopy (TFL) during inspirationDay 1Number of participants.

Secondary

MeasureTime frameDescription
Airflow registrationDay 1A 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.
Subjects perception of the examination with TFL - VAS scaleDay 1Participant'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 scaleDay 1Participant's experience of the examination will be evaluated on a Visual Analog Scale (VAS) from 0-10 where higher number indicate more discomfort.
Pressure registrationDay 1A 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.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026