Status:
COMPLETED
Facilitating Patient Communication During Noninvasive Ventilation
Lead Sponsor:
University of Utah
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Axon Medical, Inc.
Conditions:
Noninvasive Ventilation
Speech Intelligibility
Eligibility:
All Genders
18+ years
Phase:
NA
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 th...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04912544
Start Date
October 11 2021
End Date
May 9 2022
Last Update
August 1 2022
Active Locations (1)
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1
University of Utah
Salt Lake City, Utah, United States, 84112