Facilitating Patient Communication During Noninvasive Ventilation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-11

Study Completion Date

2022-05-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of the Effect of a Speech Detection Tool on the Improvement of Phonation in Neuromuscular Patients Dependent on Mechanical Ventilation

NCT03504514

Neuromuscular Diseases Mechanical Ventilation Speech

UNKNOWN NA

Testing a Novel Manual Communication System for Mechanically Ventilated ICU Patients

NCT04105751

Communication Ventilation Therapy; Complications

COMPLETED NA

Evaluation of Oxygen Delivery Through Nasal Cannula in Volunteers

NCT02886312

Oxygen Delivery Patient Monitoring Patient Comfort

COMPLETED

Optimizing Communication During Ventilation

NCT01819090

Neuromuscular Disorder Respiratory Failure

COMPLETED NA

A Feasibility Study Evaluating the Use of a Non-invasive Ventilation Mask

NCT02383719

Noninvasive Ventilation Respiratory Insufficiency

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Noninvasive Ventilation Speech Intelligibility

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

Patient talking with microphone first turned on and then off

Group Type EXPERIMENTAL

Noninvasive Ventilation Mask Microphone

Intervention Type DEVICE

Noninvasive Ventilation Mask Microphone is turned on to enhance speech intelligibility during the intervention portion of the crossover feasibility study

Arm 2

Patient talking with microphone first turned off and then on

Group Type EXPERIMENTAL

Noninvasive Ventilation Mask Microphone

Intervention Type DEVICE

Noninvasive Ventilation Mask Microphone is turned on to enhance speech intelligibility during the intervention portion of the crossover feasibility study

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Noninvasive Ventilation Mask Microphone

Noninvasive Ventilation Mask Microphone is turned on to enhance speech intelligibility during the intervention portion of the crossover feasibility study

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No