Facilitating Patient Communication During Noninvasive Ventilation

Study Overview
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Brief Summary
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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.

Detailed Description
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We will conduct a prospective feasibility study to evaluate speech intelligibility of 10 patients (target distribution of gender: 5 males, 5 females) undergoing standard of care, clinically indicated non-invasive ventilation. Patients will be their own control with and without the ReddyPort™ microphone using a crossover design, with the sequence of conditions randomized (half of patients start with microphone turned on, half start with the microphone turned off). The patients in this study will all receive standard of care. No medical decisions for a change in care will result from the speech recordings obtained during this feasibility study. The speech recordings will be analyzed off-site using a pool of blinded volunteers. The microphone on and off test conditions will not be used to change outcome of the clinical course of care.

Official Title
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Feasibility and Intelligibility Testing of a Microphone System to Facilitate Patient Communication During Noninvasive Ventilation

Conditions
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Noninvasive Ventilation, Speech Intelligibility

Intervention / Treatment
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* Device: Noninvasive Ventilation Mask Microphone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Patient talking with microphone first turned on and then off | Device: Noninvasive Ventilation Mask Microphone<br>* Noninvasive Ventilation Mask Microphone is turned on to enhance speech intelligibility during the intervention portion of the crossover feasibility study<br>|
| Experimental: Arm 2<br>Patient talking with microphone first turned off and then on | Device: Noninvasive Ventilation Mask Microphone<br>* Noninvasive Ventilation Mask Microphone is turned on to enhance speech intelligibility during the intervention portion of the crossover feasibility study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |