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

Healthy Persons Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04586855
• Other study ID #: 97615
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: April 7, 2022

Study information

• Verified date: July 2021
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 7, 2022
• Est. primary completion date: April 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy subjects

Exclusion Criteria:

• history of laryngospasm or pneumothorax

Related Conditions & MeSH terms

• Cough
• Healthy Persons

Intervention

Diagnostic Test:
• Diagnostic Ultrasound
To investigate if Ultrasound imaging can visualize the larynx during NIV and Cough Assist, and be as accurate as laryngoscopy
• Transnasal Fiberoptic Laryngoscopy
To investigate if Ultrasound imaging can visualize the larynx during NIV and Cough Assist, and be as accurate as laryngoscopy

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen	Vestlandet

Sponsors (3)

Lead Sponsor	Collaborator
Haukeland University Hospital	Sorlandet Hospital HF, St Vincent's Hospital, Sydney

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opening movements in larynx on transnasal fiberoptic laryngoscopy (TFL) during inspiration	Number of participants.	Day 1
Primary	Obstructive movements in larynx on TFL during inspiration	Number of participants.	Day 1
Primary	Closure in larynx on TFL during the compression phase of cough	Number of participants.	Day 1
Primary	Opening movements in larynx on TFL during expiration	Number of participants.	Day 1
Primary	Narrower movements in larynx on TFL during expiration	Number of participants.	Day 1
Primary	Obstructive movements in larynx on TFL during expiration	Number of participants.	Day 1
Primary	Opening movements in larynx on Anterior Ultrasound (USA) during inspiration	Number of participants.	Day 1
Primary	Obstructive movements in larynx on USA during inspiration	Number of participants.	Day 1
Primary	Closure in larynx on USA during the compression phase of cough	Number of participants.	Day 1
Primary	Opening movements in larynx on USA during expiration	Number of participants.	Day 1
Primary	Narrower movements in larynx on USA during expiration	Number of participants.	Day 1
Primary	Obstructive movements in larynx on USA during expiration	Number of participants.	Day 1
Primary	Opening movements in larynx on Lateral Ultrasound (USL) during inspiration	Number of participants.	Day 1
Primary	Obstructive movements in larynx on USL during inspiration	Number of participants.	Day 1
Primary	Closure in larynx on USL during the compression phase of cough	Number of participants.	Day 1
Primary	Opening movements in larynx on USL during expiration	Number of participants.	Day 1
Primary	Narrower movements in larynx on USL during expiration	Number of participants.	Day 1
Primary	Obstructive movements in larynx on USL during expiration	Number of participants.	Day 1
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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.	Day 1
Secondary	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
Secondary	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