Facilitating Patient Communication During Noninvasive Ventilation
- Conditions
- Speech IntelligibilityNoninvasive Ventilation
- Interventions
- Device: Noninvasive Ventilation Mask Microphone
- Registration Number
- NCT04912544
- Lead Sponsor
- University of Utah
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm 2 Noninvasive Ventilation Mask Microphone Patient talking with microphone first turned off and then on Arm 1 Noninvasive Ventilation Mask Microphone Patient talking with microphone first turned on and then off
- Primary Outcome Measures
Name Time Method Rating of speech intelligibility Intelligibility will be rated offline by blinded listeners who hear the recording 1-12 weeks after speaking tasks are complete. 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)
- Secondary Outcome Measures
Name Time Method Rating of microphone likability Immediately after speaking tasks are complete 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)
Rating of speech comprehensibility Immediately after speaking tasks are complete 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)
Rating of how natural the speech sound quality is Immediately after speaking tasks are complete 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)
Trial Locations
- Locations (1)
University of Utah
🇺🇸Salt Lake City, Utah, United States