Healthy
Conditions
Brief summary
In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the percentage of oxygen the study volunteer breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.
Interventions
DEVICELNCS DBI Sensor
Noninvasive Measurement of SpO2
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Competent non-smoking adults between the ages of 18 and 40 for each series of tests. * Subjects must understand and consent to be in the study. * American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all).
Exclusion criteria
* Subjects who have any systemic disease at all. * Subjects who do not understand the study and the risks. * Smokers. * Subjects who are pregnant. * Subjects having either signs or history of peripheral ischemia. * Others deemed ineligible by the clinical staff.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Sensor by Arms Calculation | 1-5 hours | Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of these differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Subject All subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor. | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Test Subject |
|---|---|
| Age, Customized 20-32 years | 13 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Accuracy of Sensor by Arms Calculation
Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of these differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.
Time frame: 1-5 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Subject | Accuracy of Sensor by Arms Calculation | 1.69 % of oxygen saturated hemoglobin |