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

NCT ID: NCT04586855

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-04-07

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.

Conditions

Healthy Persons

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

Healthy persons

Noninvasive ventilation and Cough Assist

Diagnostic Ultrasound

Intervention Type: DIAGNOSTIC_TEST

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

Transnasal Fiberoptic Laryngoscopy

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Diagnostic Ultrasound

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

Intervention Type: 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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Healthy subjects

Exclusion Criteria

• history of laryngospasm or pneumothorax

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St Vincent's Hospital, Sydney

OTHER

Sponsor Role: collaborator

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tiina M Andersen, PhD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

George Ntoumenopoulos, PhD

Role: STUDY_CHAIR

St Vincent's Hospital, Sydney

Maria Vollsæter, PhD

Role: STUDY_CHAIR

Haukeland University Hospital

Anne Kristine Brekka, MSc

Role: STUDY_CHAIR

Sorlandet Hospital HF

Ola D Røksund, Professor

Role: STUDY_CHAIR

Bergen University College

Locations

Haukeland University Hospital

Bergen, Vestlandet, Norway

Countries

Norway

References

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.

Reference Type: BACKGROUND

PMID: 5339574 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29666294 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 39472069 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35613803 (View on PubMed)

Other Identifiers

97615

Identifier Type: -

Identifier Source: org_study_id