Clinical trial NCT04586855: Ultrasound Imaging of the Larynx and Diaphragm During NIV and Cough Assist
Official title: Can Ultrasound Imaging of Both Upper Airways and Diaphragm Be Used to Guide Efficacy on Non-invasive Ventilation and Cough Assist
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Persons
Keywords: Transnasal Fiberoptic Laryngoscopy
Diagnostic Ultrasound
Cough Assist
Noninvasive ventilation
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: St Vincent's Hospital, Sydney
name: Sorlandet Hospital HF
First posted: 2020-10-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers will be recruited among Healthcare Professionals and medical- and physiotherapy students

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.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* history of laryngospasm or pneumothorax

Primary outcomes:
measure: Opening movements in larynx on transnasal fiberoptic laryngoscopy (TFL) during inspiration
timeFrame: Day 1
measure: Obstructive movements in larynx on TFL during inspiration
timeFrame: Day 1
measure: Closure in larynx on TFL during the compression phase of cough
timeFrame: Day 1
measure: Opening movements in larynx on TFL during expiration
timeFrame: Day 1
measure: Narrower movements in larynx on TFL during expiration
timeFrame: Day 1
measure: Obstructive movements in larynx on TFL during expiration
timeFrame: Day 1
measure: Opening movements in larynx on Anterior Ultrasound (USA) during inspiration
timeFrame: Day 1
measure: Obstructive movements in larynx on USA during inspiration
timeFrame: Day 1
measure: Closure in larynx on USA during the compression phase of cough
timeFrame: Day 1
measure: Opening movements in larynx on USA during expiration
timeFrame: Day 1
measure: Narrower movements in larynx on USA during expiration
timeFrame: Day 1
measure: Obstructive movements in larynx on USA during expiration
timeFrame: Day 1
measure: Opening movements in larynx on Lateral Ultrasound (USL) during inspiration
timeFrame: Day 1
measure: Obstructive movements in larynx on USL during inspiration
timeFrame: Day 1
measure: Closure in larynx on USL during the compression phase of cough
timeFrame: Day 1
measure: Opening movements in larynx on USL during expiration
timeFrame: Day 1
measure: Narrower movements in larynx on USL during expiration
timeFrame: Day 1
measure: Obstructive movements in larynx on USL during expiration
timeFrame: Day 1
measure: Comparison of observed movements in the larynx on transnasal fiberoptic laryngoscopy (TFL) and Anterior Ultrasound (USA) imaging.
timeFrame: Day 1
measure: Comparison of observed movements in the larynx on transnasal fiberoptic laryngoscopy (TFL) and Lateral Ultrasound (USL) imaging.
timeFrame: Day 1
measure: Comparison of observed movements in the larynx on Anterior Ultrasound (USA) and Lateral Ultrasound (USL) imaging.
timeFrame: Day 1
measure: Ultrasound imaging of diaphragm excursion
timeFrame: Day 1
Secondary outcomes:
measure: Subjects perception of the examination with TFL - VAS scale
timeFrame: Day 1
measure: Subjects perception of the examination with Laryngeal ultrasound - VAS scale
timeFrame: Day 1
measure: Airflow registration
timeFrame: Day 1
measure: Pressure registration
timeFrame: Day 1
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
state: Vestlandet
Study officials:
affiliation: Haukeland University Hospital
name: Tiina M Andersen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St Vincent's Hospital, Sydney
name: George Ntoumenopoulos, PhD
role: STUDY_CHAIR
affiliation: Haukeland University Hospital
name: Maria Vollsæter, PhD
role: STUDY_CHAIR
affiliation: Sorlandet Hospital HF
name: Anne Kristine Brekka, MSc
role: STUDY_CHAIR
affiliation: Bergen University College
name: Ola D Røksund, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.