Facilitating Patient Communication During Noninvasive Ventilation

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Speech Intelligibility; Noninvasive Ventilation

Treatments: Device: Noninvasive Ventilation Mask Microphone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04912544

00056030

1R43HL147788-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Arm 1

Experimental group

Description:

Patient talking with microphone first turned on and then off

Treatment:

Device: Noninvasive Ventilation Mask Microphone

Arm 2

Experimental group

Description:

Patient talking with microphone first turned off and then on

Treatment:

Device: Noninvasive Ventilation Mask Microphone