Accuracy of Noninvasive Pulse Oximeter Sensor (MightySat RX)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Masimo Corporation
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Accuracy of Sensor
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts 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.
- •Subjects who are pregnant.
- •Subjects having either signs or history of peripheral ischemia.
- •Others deemed ineligible by the clinical staff.
Arms & Interventions
Test Subject
All subjects are enrolled into the test group and all subjects receive the MightySat RX Pulse Oximeter Sensor.
Intervention: MightySat RX Pulse Oximeter Sensor (Device)
Outcomes
Primary Outcomes
Accuracy of Sensor
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported