Trials / Completed
CompletedNCT03592914
Respiratory Rate Accuracy Verification Clinical: Pulmonary Rehabilitation Patients
Respiratory Rate Accuracy Verification Clinical: Pulmonary Rehabilitation
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 60 (actual)
- Sponsor
- Nonin Medical, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2018-07-31
- Primary completion
- 2019-01-16
- Completion
- 2019-01-16
- First posted
- 2018-07-19
- Last updated
- 2019-03-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03592914. Inclusion in this directory is not an endorsement.