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The purpose of this clinical study is to validate the oxygen saturation (SpO2) accuracy of the RDS MultiSense® Pulse Oximetry during non-motion conditions over the range of 70-100% arterial oxygen saturation (SaO2) as compared to arterial blood samples assessed by measuring carbon monoxide (CO) bound to hemoglobin by CO-Oximetry. Additionally, data will be collected for heart rate accuracy as compared to reference ECG. The end goal is to provide supporting documentation for the SpO2 and heart rate accuracy validation for RDS MultiSense® Pulse Oximetry.
A minimum of 10 healthy adult male and female participants, ranging in age and pigmentation from light to dark, will be enrolled in the study to meet the study design requirements defined by International Organization for Standardization ISO 80601-2-61:2017: corrected version 2018-02 and by the FDA's Guidance for Pulse Oximeters (March 4, 2013). 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.
The investigational device will be placed on the placed on the thorax of the participants (patch on the upper back and external electrode on the right pectoral) per the instructions for use. Simultaneous data collection will be set up for the system under test and control oximeter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controled Hypoxia - Healthy Volunteers | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse Oximeter, Respiratory Rate, Heart Rate and Arterial line | Device | Measurement of physiological parameters |
|
| Measure | Description | Time Frame |
|---|---|---|
| Validation of SpO2 accuracy performance of RDS MultiSense® Pulse Oximeter by comparison to CO-Oximeter | The Accuracy Root Mean Square (Arms) value will be used as a metric. Reference CO-Oximetry will be used as the basis for comparison for the investigational device SpO2 readings. | From beginning to end of controled hypoxia, up to 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of heart rate accuracy performance of RDS MultiSense® by comparison to ECG-derived heart rate | The reference for comparison of the investigational device heart rate will be heart rate values collected from an ECG monitor.Heart rate accuracy will be assessed by review of the readings less than ±5 Beats Per Minute or ±10% from the Reference heart rate values. | From beginning to end of monitoring, up to 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinimark LLC | Louisville | Colorado | 80027 | United States |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D056152 | Respiratory Rate |
| D006339 | Heart Rate |
| D062666 | Vascular Access Devices |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D012119 |
| Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D006439 | Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D057785 | Catheters |
| D004864 | Equipment and Supplies |