Accuracy of Pulse Oximeters With Profound Hypoxia - Test Protocol
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- SpO2
- Sponsor
- CardiacSense Ltd.
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Accuracy of pulse oximeter with profound hypoxia
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This project aims to test the accuracy of pulse oximeters during mild, moderate, and severe hypoxia, i.e., a range of arterial HbO2 saturation from 100 down to 70%. A typical study will include at least ten subjects (at least 200 necessary data points to meet the ISO 80601-2-61:2017).
Detailed Description
After local anesthetic injection, a 22-gauge catheter is inserted in one radial artery. Pulse oximeters are attached to fingers, ears, or flat body surfaces. Subjects are in a comfortable semi-recumbent position. Subjects then breathe air mixtures containing reduced amounts of oxygen to produce the desired level of hypoxemia. Stable, safe, and controlled hypoxia is breath-by-breath by breath respiratory gas analysis and a computer program that permits the inspired gas mixture to be adjusted to achieve a level of lung alveolar gas that will achieve the desired degree of saturation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The subject is male or female, aged ≥18 and \<
- •The subject is in good general health with no evidence of any medical problems.
- •The subject is fluent in both written and spoken English.
- •The subject has provided informed consent and is willing to comply with the study procedures.
Exclusion Criteria
- •The subject is obese (BMI\>30).
- •The subject has a known history of heart disease, lung disease, kidney or liver disease.
- •Diagnosis of asthma, sleep apnea, or use of CPAP.
- •Subject has diabetes.
- •Subject has a clotting disorder.
Outcomes
Primary Outcomes
Accuracy of pulse oximeter with profound hypoxia
Time Frame: 2 days
Perform accurate measurement of a range of arterial HbO2 saturation from 100 to down to 70% during mild, moderate, and severe hypoxia.