Ultrasound Imaging of the Larynx and Diaphragm During NIV and Cough Assist
- Conditions
- Healthy Persons
- Registration Number
- NCT04586855
- Lead Sponsor
- Haukeland University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Healthy subjects
- history of laryngospasm or pneumothorax
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Opening movements in larynx on transnasal fiberoptic laryngoscopy (TFL) during inspiration Day 1 Number of participants.
Obstructive movements in larynx on TFL during inspiration Day 1 Number of participants.
Closure in larynx on TFL during the compression phase of cough Day 1 Number of participants.
Opening movements in larynx on TFL during expiration Day 1 Number of participants.
Narrower movements in larynx on TFL during expiration Day 1 Number of participants.
Obstructive movements in larynx on TFL during expiration Day 1 Number of participants.
Opening movements in larynx on Anterior Ultrasound (USA) during inspiration Day 1 Number of participants.
Obstructive movements in larynx on USA during inspiration Day 1 Number of participants.
Closure in larynx on USA during the compression phase of cough Day 1 Number of participants.
Opening movements in larynx on USA during expiration Day 1 Number of participants.
Narrower movements in larynx on USA during expiration Day 1 Number of participants.
Obstructive movements in larynx on USA during expiration Day 1 Number of participants.
Opening movements in larynx on Lateral Ultrasound (USL) during inspiration Day 1 Number of participants.
Obstructive movements in larynx on USL during inspiration Day 1 Number of participants.
Closure in larynx on USL during the compression phase of cough Day 1 Number of participants.
Opening movements in larynx on USL during expiration Day 1 Number of participants.
Narrower movements in larynx on USL during expiration Day 1 Number of participants.
Obstructive movements in larynx on USL during expiration Day 1 Number of participants.
Comparison of observed movements in the larynx on transnasal fiberoptic laryngoscopy (TFL) and Anterior Ultrasound (USA) imaging. 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. 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. Day 1 The chi-square test will assess differences between examination methods.
Ultrasound imaging of diaphragm excursion 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.
- Secondary Outcome Measures
Name Time Method Subjects perception of the examination with TFL - VAS scale Day 1 Participant's experience of the examination will be evaluated on a Visual Analog Scale (VAS) from 0-10 where higher number indicate more discomfort.
Subjects perception of the examination with Laryngeal ultrasound - VAS scale Day 1 Participant's experience of the examination will be evaluated on a Visual Analog Scale (VAS) from 0-10 where higher number indicate more discomfort.
Airflow registration Day 1 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.
Pressure registration Day 1 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.
Trial Locations
- Locations (1)
Haukeland University Hospital
🇳🇴Bergen, Vestlandet, Norway
Haukeland University Hospital🇳🇴Bergen, Vestlandet, Norway