Clinical trial NCT04912544: Facilitating Patient Communication During Noninvasive Ventilation
Official title: Feasibility and Intelligibility Testing of a Microphone System to Facilitate Patient Communication During Noninvasive Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Noninvasive Ventilation
Speech Intelligibility
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Axon Medical, Inc.
name: Intermountain Medical Center
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-06-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rating of speech intelligibility
timeFrame: Intelligibility will be rated offline by blinded listeners who hear the recording 1-12 weeks after speaking tasks are complete.
Secondary outcomes:
measure: Rating of microphone likability
timeFrame: Immediately after speaking tasks are complete
measure: Rating of speech comprehensibility
timeFrame: Immediately after speaking tasks are complete
measure: Rating of how natural the speech sound quality is
timeFrame: Immediately after speaking tasks are complete
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Lara Brewer, PhD
role: PRINCIPAL_INVESTIGATOR
References: