Facilitating Patient Communication During Noninvasive Ventilation

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

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.

Study Overview

• Status: Completed
• Conditions: Noninvasive Ventilation; Speech Intelligibility
• Intervention / Treatment: Device: Noninvasive Ventilation Mask Microphone

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institute of Nursing Research (NINR); Intermountain Medical Center; Axon Medical, Inc.
• Investigators: Principal Investigator: Lara Brewer, PhD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2021
• Primary Completion (Actual): April 15, 2022
• Study Completion (Actual): May 9, 2022

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: June 1, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 00056030; 1R43HL147788-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No