Respiratory Insufficiency
Conditions
Brief summary
Study Design: This study is a comparative, single-center study. This is a minimal risk study (as defined in 21 CFR Part 56) using a non-significant risk device (as defined in 21 CFR Part 812.3). A minimum of 60 subjects will be enrolled in the study. Subject participation will last approximately 1 hour.
Detailed description
Study Design: This study is a comparative, single-center study. This is a minimal risk study (as defined in 21 CFR Part 56) using a non-significant risk device (as defined in 21 CFR Part 812.3). A minimum of 60 subjects will be enrolled in the study. Subject participation will last approximately 1 hour. Objective(s): The primary objective of this study is to evaluate the two Fingertip Respiratory Rate (FTRR) algorithms performance of Nonin's Onyx 3 by attempting to demonstrate a mean error for FTRR \< 1.0 BPM during spontaneous breathing.
Interventions
None listed
Sponsors
Valley Inspired Products
Nonin Medical, Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject is at least 18 years old; * The subject has given written informed consent to participate in the study; * The subject is both willing and able to comply with study procedures.
Exclusion criteria
* The subject has a history of or current atrial fibrillation; * The subject has a documented history of frequent premature ventricular contractions (PVCs), defined as \>3 per 30 seconds; * The subject has an implanted pacemaker; * The subject has had any relevant injury at the sensor location site (self-reported); * The subject has deformities or abnormalities that may prevent proper application of the device under test (based on examination); * The subject is currently or trying to get pregnant (self-reported); and/or * The subject has another health condition which in the opinion of the principal investigator makes subject unsuitable for testing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the two Fingertip Respiratory Rate (FTRR) algorithms performance of Nonin's Onyx 3 | 40 minutes | Measure respiratory rates |
Countries
United States
Outcome results
None listed