Healthy PersonsNCT04586855
Ultrasound Imaging of the Larynx and Diaphragm During NIV and Cough Assist
An observational study of Healthy Persons, run by Haukeland University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Persons
- What is being tested?
- Diagnostic Ultrasound and Transnasal Fiberoptic Laryngoscopy
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2022to 7 Apr 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers will be recruited among Healthcare Professionals and medical- and physiotherapy students
Who may be able to join
- Healthy subjects
Who cannot join
- history of laryngospasm or pneumothorax
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Ultrasound Imaging of Both Upper Airways and Diaphragm be Used to Guide Efficacy on Non-invasive Ventilation 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.
Read the 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.
- Conditions
- Healthy Persons
- Being tested
- Diagnostic Ultrasound, Transnasal Fiberoptic Laryngoscopy
- Keywords
- Transnasal Fiberoptic Laryngoscopy, Diagnostic Ultrasound, Cough Assist, Noninvasive ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic UltrasoundDiagnostic test
To investigate if Ultrasound imaging can visualize the larynx during NIV and Cough Assist, and be as accurate as laryngoscopy
Transnasal Fiberoptic LaryngoscopyDiagnostic test
To investigate if Ultrasound imaging can visualize the larynx during NIV and Cough Assist, and be as accurate as laryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| Healthy persons | Noninvasive ventilation and Cough Assist Receives: Diagnostic Test: Diagnostic Ultrasound; Diagnostic Test: Transnasal Fiberoptic Laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opening movements in larynx on transnasal fiberoptic laryngoscopy (TFL) during inspiration
Number of participants.
Measured: Day 1
Obstructive movements in larynx on TFL during inspiration
Number of participants.
Measured: Day 1
Closure in larynx on TFL during the compression phase of cough
Number of participants.
Measured: Day 1
Opening movements in larynx on TFL during expiration
Number of participants.
Measured: Day 1
Narrower movements in larynx on TFL during expiration
Number of participants.
Measured: Day 1
Obstructive movements in larynx on TFL during expiration
Number of participants.
Measured: Day 1
Opening movements in larynx on Anterior Ultrasound (USA) during inspiration
Number of participants.
Measured: Day 1
Obstructive movements in larynx on USA during inspiration
Number of participants.
Measured: Day 1
Closure in larynx on USA during the compression phase of cough
Number of participants.
Measured: Day 1
Opening movements in larynx on USA during expiration
Number of participants.
Measured: Day 1
Narrower movements in larynx on USA during expiration
Number of participants.
Measured: Day 1
Obstructive movements in larynx on USA during expiration
Number of participants.
Measured: Day 1
Opening movements in larynx on Lateral Ultrasound (USL) during inspiration
Number of participants.
Measured: Day 1
Obstructive movements in larynx on USL during inspiration
Number of participants.
Measured: Day 1
Closure in larynx on USL during the compression phase of cough
Number of participants.
Measured: Day 1
Opening movements in larynx on USL during expiration
Number of participants.
Measured: Day 1
Narrower movements in larynx on USL during expiration
Number of participants.
Measured: Day 1
Obstructive movements in larynx on USL during expiration
Number of participants.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1
Secondary outcomes (4)
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.
Measured: Day 1
Subjects perception of the examination with Laryngeal ultrasound - 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.
Measured: 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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Jan 2022
- Primary completion7 Apr 2022
- Study completion7 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy PersonsStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St Vincent's Hospital, Sydney, Sorlandet Hospital HF
- Responsible party
- Sponsor
- Investigators
- Tiina M Andersen, PhD, Principal investigator, Haukeland University HospitalGeorge Ntoumenopoulos, PhD, Study chair, St Vincent's Hospital, SydneyMaria Vollsæter, PhD, Study chair, Haukeland University HospitalAnne Kristine Brekka, MSc, Study chair, Sorlandet Hospital HFOla D Røksund, Professor, Study chair, Bergen University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586855
- Sponsor's protocol ID
- 97615
- Status last verified
- Jul 2021
- First submitted
- 27 Jul 2020
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27174631Andersen 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.
PubMed 29666294Brekka 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.
PubMed 35613803Brekka 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.
PubMed 39472069
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Ultrasound Imaging of Both Upper Airways and Diaphragm be Used to Guide Efficacy on Non-invasive Ventilation and Cough Assist
- ClinicalTrials.gov ID
- NCT04586855
- Acronym / sponsor ID
- 97615
- Conditions
- Healthy Persons
- Keywords
- Transnasal Fiberoptic Laryngoscopy, Diagnostic Ultrasound, Cough Assist, Noninvasive ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- St Vincent's Hospital, Sydney, Sorlandet Hospital HF
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 7 Apr 2022 (actual)
- Study completion
- 7 Apr 2022 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy persons | – | Diagnostic Test: Diagnostic Ultrasound, Diagnostic Test: Transnasal Fiberoptic LaryngoscopyNoninvasive ventilation and Cough Assist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers will be recruited among Healthcare Professionals and medical- and physiotherapy students
Key inclusion criteria (1 listed)
- Healthy subjects
Key exclusion criteria (1 listed)
- history of laryngospasm or pneumothorax
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic UltrasoundTo investigate if Ultrasound imaging can visualize the larynx during NIV and Cough Assist, and be as accurate as laryngoscopy | Diagnostic test | Healthy persons |
| Transnasal Fiberoptic LaryngoscopyTo investigate if Ultrasound imaging can visualize the larynx during NIV and Cough Assist, and be as accurate as laryngoscopy | Diagnostic test | Healthy persons |
Primary outcome
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.
4 secondary outcomes
Subjects perception of the examination with TFL - VAS scale
Time frame: Day 1
Subjects perception of the examination with Laryngeal ultrasound - VAS scale
Time frame: Day 1
Airflow registration
Time frame: Day 1
Pressure registration
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Background: PubMed 27174631Andersen 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.
- Background: PubMed 29666294Andersen 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.
- Background: PubMed 35613803Brekka 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.
- Results publication: PubMed 39472069Brekka 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Persons, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opening movements in larynx on transnasal fiberoptic laryngoscopy (TFL) during inspiration (time frame: Day 1). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04586855, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.