Validation Study
Conditions
Brief summary
The purpose of this study is to evaluate the SpO2 accuracy performance of the Sunrise Sensor 2 placed at the tip of the chin during non-motion conditions over the range of 70-100% by comparison to SaO2 values determined from arterial blood sample specimen analyzed by a CO-oximeter. Testing is conducted under normal office environment conditions. It is expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system will meet the required specification of ARMS of 3.5% or less allowed for reflectance technology in non-motion conditions for the range of 70-100% SaO2. A secondary goal is to evaluate the pulse rate performance simultaneously collected over the SpO2 range covered.
Detailed description
Subjects will be given medical grade mixtures of oxygen and nitrogen to induce stable plateaus across the range of 100% to 70% SaO2. When the reference system's blood saturation stabilizes at an acceptable plateau level, blood sampling can start. Four to eight arterial blood samples will be collected for each plateau, while keeping at least 20 seconds in between each sample and at least 30 seconds once the plateau has been reached. The blood will be immediately analyzed by the reference CO-Oximeter to measure the arterial oxygen saturation (Functional SaO2). SpO2 values from the Sunrise sensor 2 will be collected electronically simultaneously to blood drawn from the indwelling catheter. Data will be collected under non-motion conditions. The pulse rate will be simultaneously collected over the SpO2 range covered. The reference method for the computation of pulse rate accuracy will be an ECG heart rate. The total duration of the test will be about 1 hour per subject. Data analysis results will provide documentation showing SpO2 and pulse rate accuracy performance of the Sunrise sensor 2 as compared to arterial blood samples measured by Reference CO-Oximetry and to ECG heart rate, respectively.
Interventions
DEVICEPulse oximeter validation population
Evaluation of the SpO2 accuracy performance of the Sunrise Sensor 2 placed at the tip of the chin during non-motion conditions over the range of 70-100% by comparison to SaO2 values determined from arterial blood sample specimen analyzed by a CO-oximeter.
Sponsors
Sunrise
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects with positive Allen's test * Subject must be willing and able to comply with study procedures and duration * Subject is a non-smoker or who has not smoked within 2 days prior to the study * 15% of the study population or 2 subjects (whichever is larger) with dark pigmented skin should be included in the study
Exclusion criteria
* Subject is considered as being morbidly obese (defined as BMI \>39.5) * Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study * Subjects with known heart or cardiovascular conditions * Subjects with other known health condition (diabetes, thyroid disease, kidney disease/chronic renal impairment, history of seizures (except childhood febrile seizures) or epilepsy, or unexplained syncope, recent history of frequent migraine headaches, recent head injury, cancer/chemotherapy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SpO2 ARMS determination | Within 1 month after subject recruitment | SpO2 accuracy root-mean-square (ARMS) determination for the range of 70- 100%., i.e., the RMS difference between measured values and reference values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulse rate ARMS determination | Within 1 month after subject recruitment | Pulse rate accuracy root-mean-square (ARMS) determination |
Countries
Belgium
Outcome results
None listed