Hypoxia
Conditions
Brief summary
The goal of this clinical trial is to compare values of SpO2 provided by the DUT and the SaO2 used as a reference in healthy adults. The main question it aims to answer is: what is the accuracy of the subject device compared to the 510(k)-cleared reference device A radial arterial cannula was placed in the wrist of each subject for arterial blood sampling and a subject device was placed on each arm of the patients. Then, hypoxia was induced to different stable levels of oxyhemoglobin saturation between 70-100% by having subjects breathe mixtures of nitrogen, air, and carbon dioxide controlled by the study physician. Values of SpO2 and SaO2 were then compared to provide a root mean square error and conclude on the subject device accuracy.
Interventions
COMBINATION_PRODUCTMixtures of nitrogen, air, and carbon dioxide
Hypoxia was induced to different and stable levels of oxyhemoglobin saturation (between 70-100%) by having subjects breathe mixtures of nitrogen, air, and carbon dioxide controlled by the study physician by adjusting gas flows with valves according to breath-by-breath estimates of oxygen saturation calculated from end-tidal PO2 and PCO2 displayed on a screen using LabVIEW 2015
Sponsors
Gabi SmartCare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult * Normal hemoglobin levels (Hemoglobin \> 10 g/dL)
Exclusion criteria
* Systemic illness * Obesity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of Accuracy (ARMS [%]) | 1 hour | Arms, given in percentage or rms error, is the calculation of root mean square between SpO2 values from the subject device and the SaO2 from the Hemoximeter. It is a way of averaging the absolute values of errors over the full measurement range and is a similar measurmeent to a rms error. It indicates how far (accurate) the provided value is from the reference used. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Adults Healthy adults
Mixtures of nitrogen, air, and carbon dioxide: Hypoxia was induced to different and stable levels of oxyhemoglobin saturation (between 70-100%) by having subjects breathe mixtures of nitrogen, air, and carbon dioxide controlled by the study physician by adjusting gas flows with valves according to breath-by-breath estimates of oxygen saturation calculated from end-tidal PO2 and PCO2 displayed on a screen using LabVIEW 2015. 2 Gabi Band devices were placed on the subject (one on each arm). It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.5% or less. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Healthy Adults |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 25.25 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 12 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Measure of Accuracy (ARMS [%])
Arms, given in percentage or rms error, is the calculation of root mean square between SpO2 values from the subject device and the SaO2 from the Hemoximeter. It is a way of averaging the absolute values of errors over the full measurement range and is a similar measurmeent to a rms error. It indicates how far (accurate) the provided value is from the reference used.
Time frame: 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Healthy Adults | Measure of Accuracy (ARMS [%]) | 2.95 Percentage |