Viewing Study NCT04586855



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Last Modification Date: 2024-10-26 @ 1:47 PM
Study NCT ID: NCT04586855
Status: COMPLETED
Last Update Posted: 2023-01-31
First Post: 2020-07-27

Brief Title: Ultrasound Imaging of the Larynx and Diaphragm During NIV and Cough Assist
Sponsor: Haukeland University Hospital
Organization: Haukeland University Hospital

Study Overview

Official Title: Can Ultrasound Imaging of Both Upper Airways and Diaphragm be Used to Guide Efficacy on Non-invasive Ventilation and Cough Assist
Status: COMPLETED
Status Verified Date: 2021-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None