Pulse Oximetry
Conditions
Brief summary
A study to test the accuracy of SpO2 sensors with various patient monitors, co-oximeters, and modules.
Detailed description
The U-TruSignal with different sensors is feasible for noninvasive and continuous SpO2 monitoring and meets the specified measurement accuracy when compared to a co-oximetry gold reference.
Interventions
DEVICEPulse oximetry
Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.
Sponsors
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Ability to provide written informed consent or have a legally authorized representative provide written informed consent * Subjects who are 18-55 years of age * Subjects must be willing and able to comply with study procedures * HbCO\<3% (for smokers only)
Exclusion criteria
* Subject or a legally authorized representative is unable to provide written inform consent. * Subjects that are considered morbidly obese (defined as BMI \> 39.5), * Subjects with injuries, deformities or abnormalities that may prevent proper application of the device under test, * Smokers with COHb levels \>3% or subjects who have smoked within two (2) days. Subjects will be screened for COHb levels of \>3% with a Masimo Radical 7 (Rainbow). * Subjects with known respiratory conditions (uncontrolled asthma, head cold, flu, pneumonia / bronchitis, respiratory distress / respiratory or lung surgery, emphysema, COPD, lung disease), * Subjects with known heart or cardiovascular conditions, * Female subjects that are actively trying to get pregnant or are pregnant, * Subjects taking blood thinners or medications with aspirin or other antiplatelet medication in them (applies only to arterial draw study), * Subjects with Systolic blood pressure \>140mmHg, * Subjects with Diastolic blood pressure \>100mmHg, * Subjects with heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy Root Mean Square (ARMS) | 60 minutes | The Accuracy Root Mean Square (ARMS) calculation is used to measure accuracy of the test SpO2 device compared to reference SpO2 device. A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around the line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square (ARMS). The smaller ARMs the closer the data points lie around the line of identity, representing a more accurate sensor as accurate and appropriate. Data analysis follows ISO 80601-2-61, 2011, Annex EE and the FDA Guidance Document for Pulse Oximeters (FDA Draft Guidance, July 19, 2007). |
Countries
United States
Participant flow
Recruitment details
The first subject was enrolled on June19, 2012 and the last subject was enrolled on February 15, 2013. The study was conducted at Clinimark, a human performance laboratory that tests physiological monitoring devices.
Participants by arm
| Arm | Count |
|---|---|
| Pulse Oximetry Monitoring Pulse Oximetry Monitoring Single Arm | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Reused disposable sensors | 10 |
| Overall Study | Unable to place arterial line | 1 |
Baseline characteristics
| Characteristic | Pulse Oximetry Monitoring |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants |
| Age, Continuous | 23.4 years STANDARD_DEVIATION 3.8 |
| Region of Enrollment United States | 51 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 23 Participants |
| SpO2 | 95.1 % oxygen STANDARD_DEVIATION 1.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 63 | 0 / 63 | 0 / 63 | 0 / 63 | 0 / 63 | 0 / 63 | 0 / 63 | 0 / 63 | 0 / 63 |
| other Total, other adverse events | 0 / 63 | 0 / 63 | 0 / 63 | 0 / 63 | 0 / 63 | 0 / 63 | 0 / 63 | 0 / 63 | 0 / 63 | 0 / 63 |
| serious Total, serious adverse events | 0 / 63 | 0 / 63 | 0 / 63 | 0 / 63 | 0 / 63 | 0 / 63 | 0 / 63 | 0 / 63 | 0 / 63 | 0 / 63 |
Outcome results
Primary
Accuracy Root Mean Square (ARMS)
The Accuracy Root Mean Square (ARMS) calculation is used to measure accuracy of the test SpO2 device compared to reference SpO2 device. A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around the line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square (ARMS). The smaller ARMs the closer the data points lie around the line of identity, representing a more accurate sensor as accurate and appropriate. Data analysis follows ISO 80601-2-61, 2011, Annex EE and the FDA Guidance Document for Pulse Oximeters (FDA Draft Guidance, July 19, 2007).
Time frame: 60 minutes
Population: The data analyzed was SpO2 data pairs using different U-Trusginal SpO2 sensors, patient monitors, co-oximeters, and various modules. Multiple data pairs were collected from each study participant, but not all sensors, patient monitors, co-oximeters and module configurations were used with each participant.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Pulse Oximetry Monitoring Using SpO@ Sensors | Accuracy Root Mean Square (ARMS) | TS-AAW Sensor + B40 Patient Monitor | 1.488 Accuracy Root Mean Square |
| Pulse Oximetry Monitoring Using SpO@ Sensors | Accuracy Root Mean Square (ARMS) | TS-AAW Sensor + 3900 Oximeter | 1.465 Accuracy Root Mean Square |
| Pulse Oximetry Monitoring Using SpO@ Sensors | Accuracy Root Mean Square (ARMS) | TS-AAW Sensor + Carescape V100 & UTrusignal V2 | 1.651 Accuracy Root Mean Square |
| Pulse Oximetry Monitoring Using SpO@ Sensors | Accuracy Root Mean Square (ARMS) | TS-SA-D Sensor + TruSat | 1.523 Accuracy Root Mean Square |
| Pulse Oximetry Monitoring Using SpO@ Sensors | Accuracy Root Mean Square (ARMS) | TS-AAW Sensor + TruffSat | 1.286 Accuracy Root Mean Square |
| Pulse Oximetry Monitoring Using SpO@ Sensors | Accuracy Root Mean Square (ARMS) | TS-AAW Sensor + Carescape V100 | 1.352 Accuracy Root Mean Square |
| Pulse Oximetry Monitoring Using SpO@ Sensors | Accuracy Root Mean Square (ARMS) | TS-AAW Sensor + EPRESTN | 2.179 Accuracy Root Mean Square |
| Pulse Oximetry Monitoring Using SpO@ Sensors | Accuracy Root Mean Square (ARMS) | TS-AAW Sensor + M-NESTPR | 1.813 Accuracy Root Mean Square |
| Pulse Oximetry Monitoring Using SpO@ Sensors | Accuracy Root Mean Square (ARMS) | TS-AAW Sensor + M-OSAT | 1.496 Accuracy Root Mean Square |
| Pulse Oximetry Monitoring Using SpO@ Sensors | Accuracy Root Mean Square (ARMS) | TS-AAW Sensor + TruSat | 1.612 Accuracy Root Mean Square |