SpO2 Validation Study - All.Health Algo Oximeter Software
All Health, Inc.
Summary
The clinical use of pulse oximeters has reduced the frequency and necessity of invasive arterial blood sampling and has helped to improve patient safety by providing continuous information to clinicians about patients' oxygenation status. all.health is dedicated to developing and applying innovative electronic medical solutions that improve patient care with the Algo Oximeter Software, to be used in applications for monitoring oxygen saturation.
Description
The purpose of this clinical study is to validate the SpO2 accuracy performance of the all.health SpO2 sensors over the range of 70-100% SaO2 during non-motion conditions assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the all.health pulse oximeter. The participants will have an arterial catheter placed in the radial artery to allow for simultaneous blood samples during stable plateaus of induced hypoxic levels. An investigational device will be placed on the wrist of the side opposite the arterial catheter following the instruc…
Eligibility
- Age range
- 22–50 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Participant must have the ability to understand and provide written informed consent. * Participant is adult 22-50 years of age. * Participant must be willing and able to comply with study procedures and duration. * Participant is a non-smoker or who has not smoked within 2 days prior to the study. * Male or female of any race. Exclusion Criteria: * Participant has a resting SpO2 \< 92% as assessed by a pulse oximeter * Participant is considered as being morbidly obese (defined as BMI \>39.5) * Compromised circulation (i.e., Raynaud's Syndrome), injury, or physical mal…
Interventions
- DeviceNo intervention (observational study)
No intervention
Location
- Element Materials TechnologyLouisville, Colorado