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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Persons
• Intervention / Treatment: Diagnostic test: Diagnostic Ultrasound; Diagnostic test: Transnasal Fiberoptic Laryngoscopy

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Norway
  • Vestlandet
    • Bergen, Vestlandet, Norway, 5021
      • Haukeland University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers will be recruited among Healthcare Professionals and medical- and physiotherapy students

Description

Inclusion Criteria:

• Healthy subjects

Exclusion Criteria:

• history of laryngospasm or pneumothorax

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy persons; Noninvasive ventilation and Cough Assist	Diagnostic test: Diagnostic Ultrasound; To investigate if Ultrasound imaging can visualize the larynx during NIV and Cough Assist, and be as accurate as laryngoscopy; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: Sorlandet Hospital HF; St Vincent's Hospital, Sydney
• Investigators: Principal Investigator: Tiina M Andersen, PhD, Haukeland University Hospital; Study Chair: George Ntoumenopoulos, PhD, St Vincent's Hospital, Sydney; Study Chair: Maria Vollsæter, PhD, Haukeland University Hospital; Study Chair: Anne Kristine Brekka, MSc, Sorlandet Hospital HF; Study Chair: Ola D Røksund, Professor, Bergen University College

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): April 7, 2022
• Study Completion (Actual): April 7, 2022

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): January 31, 2023
• Last Update Submitted That Met QC Criteria: January 30, 2023
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Noninvasive ventilation; Cough Assist; Diagnostic Ultrasound; Transnasal Fiberoptic Laryngoscopy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: 97615

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No