Hypoxia
Conditions
Brief summary
The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest.
Detailed description
This study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically, SpO2 and pulse rate accuracy will be assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients at rest.
Interventions
DEVICEPulse Oximeter
OLV-4202 pulse oximeter (SW version: 01-15)
Sponsors
University of California, San Francisco
Nihon Kohden
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Both male and female subjects who can give written informed consent * Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile below * Meeting the demographic requirements
Exclusion criteria
* Age below 18 or over 50 * Pregnant women * Significant arrhythmia * Blood pressure above 150 systolic or 90 diastolic * Carboxyhemoglobin levels over 3% * Subjects whom the investigator consider ineligible for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Sensor Oxygen Saturation by Arms Calculation | 30 seconds | Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter (SpO2i) to that obtained from a blood sample (SRi) and calculating the arithmetic root mean square (Arms) error value as follows: Arms = Square root (sum of n samples of ((SpO2i - SRi) squared) / n) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Sensor Pulse Rate by Arms Calculation | 30 seconds | Accuracy will be determined by comparing the noninvasive pulse rate measurement of the pulse oximeter (PRi) to the heart rate obtained from an electrocardiography reference device (HRRi) and calculating the arithmetic root mean square (Arms) error value as follows: Arms = Square root (sum of n samples of ((PRi - HRRi) squared) / n) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adult Healthy Subjects Adult healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile in an at rest state
Pulse Oximeter: OLV-4202 pulse oximeter (SW version: 01-15) | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Adult Healthy Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Race/Ethnicity, Customized African | 2 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Caucasian | 5 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants |
| Race/Ethnicity, Customized Multiethnic | 1 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Accuracy of Sensor Oxygen Saturation by Arms Calculation
Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter (SpO2i) to that obtained from a blood sample (SRi) and calculating the arithmetic root mean square (Arms) error value as follows: Arms = Square root (sum of n samples of ((SpO2i - SRi) squared) / n)
Time frame: 30 seconds
Population: Qualified subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Healthy Subjects | Accuracy of Sensor Oxygen Saturation by Arms Calculation | 2.0 percentage of SpO2 |
Secondary
Accuracy of Sensor Pulse Rate by Arms Calculation
Accuracy will be determined by comparing the noninvasive pulse rate measurement of the pulse oximeter (PRi) to the heart rate obtained from an electrocardiography reference device (HRRi) and calculating the arithmetic root mean square (Arms) error value as follows: Arms = Square root (sum of n samples of ((PRi - HRRi) squared) / n)
Time frame: 30 seconds
Population: Qualified subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Healthy Subjects | Accuracy of Sensor Pulse Rate by Arms Calculation | 2.0 percentage of SpO2 |