Noninvasive Ventilation Clinical Trial
Official title:
Feasibility and Intelligibility Testing of a Microphone System to Facilitate Patient Communication During Noninvasive Ventilation
Verified date | July 2022 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Assessing speech intelligibility in a pilot study of patients speaking with a mask microphone while being treated with standard of care non-invasive ventilation. This is a feasibility study to test the microphone in a real world setting.
Status | Completed |
Enrollment | 10 |
Est. completion date | May 9, 2022 |
Est. primary completion date | April 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age greater than or equal to 18 years - Currently hospitalized - Awake and able to attempt communication - Respiratory failure requiring non-invasive ventilatory support - Positive Inspiratory Pressure (PIP) less than or equal to 20 cm H2O - Positive End Expiratory Pressure (PEEP) less than or equal to 10 cm H2O - FiO2 less than or equal to 0.60 - Clinical attending physician believes it is safe for the patient to participate - Able to consent o If patient cannot consent on the basis of difficulty in being heard and asking questions (as in fact may occur with NIV, a key assumption of this study), then assent will be obtained from the patient with informed consent obtained from a legally authorized representative. Exclusion Criteria: - Tachypnea with RR > 35 - Increase in PIP, PEEP or FiO2 over the last 2 hours - Known to be delirious (clinically obtained CAM score that is positive) - Prisoner |
Country | Name | City | State |
---|---|---|---|
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah | Axon Medical, Inc., Intermountain Medical Center, National Heart, Lung, and Blood Institute (NHLBI), National Institute of Nursing Research (NINR) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rating of speech intelligibility | The 1-5 likert scale developed by Yorkston et al will be used to evaluate speech intelligibility of the device (Yorkston, Kathryn M., David R. Beukelman, and Charles Traynor. Assessment of intelligibility of dysarthric speech. Austin, TX: Pro-ed, 1984.Powell TW. A comparison of English reading passages for elicitation of speech samples from clinical populations. Clin Linguist Phon. 2006;20(2-3):91-7) | Intelligibility will be rated offline by blinded listeners who hear the recording 1-12 weeks after speaking tasks are complete. | |
Secondary | Rating of microphone likability | Subjects will be asked how well they liked using the microphone on a Likert-type scale of 1-5, from extremely unlikable (1) to extremely likable (5) | Immediately after speaking tasks are complete | |
Secondary | Rating of speech comprehensibility | Subjects will be asked how well they could understand the speech on a Likert-type scale of 1-5, from not at all understandable (1) to fully understandable (5) | Immediately after speaking tasks are complete | |
Secondary | Rating of how natural the speech sound quality is | Subjects will be asked how natural the speech sound quality is on a Likert-type scale of 1-5, from not natural (1) to completely natural (5) | Immediately after speaking tasks are complete |
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