Healthy
Conditions
Brief summary
In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration 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
DEVICEMightySat RX Pulse Oximeter Sensor
Noninvasive pulse oximeter finger sensor.
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 Inclusion Criteria: * 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 | 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 error (Arms) value. |
| Accuracy of Sensor during motion | 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 during motion conditions and calculating the arithmetic root mean square error (Arms) value. |
Countries
United States
Outcome results
None listed