Oxitone Sp02 Hypoxia Test Versus Reference Pulse Oximetry
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 4/21/2017 |
| Start Date: | August 2016 |
| End Date: | September 2016 |
The purpose of this study is to conduct a SpO2 hypoxia evaluation of the Oxitone Medical
Oxitone 1000 pulse oximeter. The Oxitone 1000 pulse oximeter will be evaluated during
non-motion conditions over the range of 70-100% SpO2 in comparison to a Reference Pulse
Oximeter.
The study is observational in nature which quantifies device performance and accuracy in
compassion to a Reference Pulse Oximeter.
Oxitone 1000 pulse oximeter. The Oxitone 1000 pulse oximeter will be evaluated during
non-motion conditions over the range of 70-100% SpO2 in comparison to a Reference Pulse
Oximeter.
The study is observational in nature which quantifies device performance and accuracy in
compassion to a Reference Pulse Oximeter.
The purpose of this study is to conduct a SpO2 hypoxia evaluation of the Oxitone Medical
Oxitone 1000 pulse oximeter. The Oxitone 1000 pulse oximeter will be evaluated during
non-motion conditions over the range of 70-100% SpO2 in comparison to a Reference Pulse
Oximeter. The end goal is to show the SpO2 accuracy performance of the Oxitone 1000 and if
needed, use the data to make improvements prior to an arterial blood hypoxia study.
A Clinimark 3900 Reference Pulse Oximeter or Nellcor N-600x will be used for the SpO2
calibration. There are no risks or adverse device effects to be assessed. There are no
contraindications for use in the proposed study / study population
The Control Pulse Oximeter, GE Healthcare (Datex-Ohmeda) 3900, an FDA cleared device, is
used to monitor the oxygen saturation levels real time throughout the study for subject
safety and to target stable plateaus. This device is used to assess the stability of the
data.
Oxitone 1000 pulse oximeter. The Oxitone 1000 pulse oximeter will be evaluated during
non-motion conditions over the range of 70-100% SpO2 in comparison to a Reference Pulse
Oximeter. The end goal is to show the SpO2 accuracy performance of the Oxitone 1000 and if
needed, use the data to make improvements prior to an arterial blood hypoxia study.
A Clinimark 3900 Reference Pulse Oximeter or Nellcor N-600x will be used for the SpO2
calibration. There are no risks or adverse device effects to be assessed. There are no
contraindications for use in the proposed study / study population
The Control Pulse Oximeter, GE Healthcare (Datex-Ohmeda) 3900, an FDA cleared device, is
used to monitor the oxygen saturation levels real time throughout the study for subject
safety and to target stable plateaus. This device is used to assess the stability of the
data.
Inclusion Criteria:
- Healthy individuals between the age of 18-50
Exclusion Criteria:
- Clotting disorders, diabetes, currently taking psychotropic medications
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