Trials / Completed
CompletedNCT04814342
Accuracy of Pulse Oximeters With Profound Hypoxia During Motion
Determination of SpO2 and PR Accuracy Specifications During Motion Accuracy of Pulse Oximeters With Profound Hypoxia Pulse Oximeter Accuracy Evaluation Protocol
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 5 (actual)
- Sponsor
- Nihon Kohden · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients during controlled motion.
Detailed description
This study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically, SpO2 and pulse rate accuracy will be assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients during controlled motion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Pulse oximeter | OLV-4202 pulse oximeter (SW version: 01-11) |
Timeline
- Start date
- 2021-03-24
- Primary completion
- 2021-05-24
- Completion
- 2022-02-15
- First posted
- 2021-03-24
- Last updated
- 2025-09-12
- Results posted
- 2023-11-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04814342. Inclusion in this directory is not an endorsement.