Healthy
Conditions
Brief summary
Assess the accuracy of INVSENSOR00069's peripheral oxygen saturation (SpO2) against contemporaneous measurement from arterial blood gas (ABG) analysis.
Interventions
DEVICEINVSENSOR00069
Noninvasive pulse oximeter
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Influenced by study design: * Subject is 18 to 50 years of age. * Subject weighs a minimum of 110 lbs. * Hemoglobin value ≥ 11 g/dL. * Baseline heart rate ≥ 45 bpm and ≤ 90 bpm. * Systolic blood pressure ≤ 140 mmHg and ≥ 90 mmHg and diastolic blood pressure ≤ 90 mmHg and ≥ 50 mmHg. If systolic blood pressure is lower than 100 mmHg and/or diastolic blood pressure is lower than 60 mmHg, subject passes an orthostatic blood pressure test. * CO value ≤ 3.0% FCOHb. * Subject is comfortable to read and communicate in English\*. \*This is to ensure the subject can provide informed consent (as study materials are currently available in English only) and can comply with study procedures.
Exclusion criteria
Influenced by device warning labels: * Subjects with a skin condition affecting the digits, where the sensor is applied, which would interfere with the path of light (e.g., psoriasis, vitiligo, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, etc.). * Subjects with nail polish or acrylic nails on the digits where sensor needs to be applied, who opt not to remove them. * Subject has hemoglobinopathies or synthesis disorders (e.g., thalassemia, sickle cell disease). * Subject has a peripheral vascular or vasospastic disease (e.g., Raynaud's disease). Influenced by study design/environment: * Subjects who do not pass the health assessment for safe participation in the study procedures. * Difficulty inserting an intravenous line in the subject's hand or arm and/or an arterial line in the radial artery of the subject's wrist.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SpO2 Accuracy of Masimo INVSENSOR00069 | 1-3 hours | The SpO2 accuracy of Masimo INVSENSOR00069 was determined by calculating the accuracy root mean-squared (Arms) difference between the measured values (SpO2) to the reference values (SaO2) in accordance with ISO-80601-2-61. Arms= √(∑(i=1 to n) ((SpO2\_i-SaO2\_i )\^2 ))/n. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Masimo INVSENSOR00069 All subjects who are enrolled into the test group and participate in data collection have the Masimo INVSENSOR00069.
INVSENSOR00069: Noninvasive pulse oximeter | 36 |
| Total | 36 |
Baseline characteristics
| Characteristic | Masimo INVSENSOR00069 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 36 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 86 |
| other Total, other adverse events | 9 / 86 |
| serious Total, serious adverse events | 0 / 86 |
Outcome results
Primary
SpO2 Accuracy of Masimo INVSENSOR00069
The SpO2 accuracy of Masimo INVSENSOR00069 was determined by calculating the accuracy root mean-squared (Arms) difference between the measured values (SpO2) to the reference values (SaO2) in accordance with ISO-80601-2-61. Arms= √(∑(i=1 to n) ((SpO2\_i-SaO2\_i )\^2 ))/n.
Time frame: 1-3 hours
Population: 10 subjects not analyzed due to incorrect sensor 3 subjects not analyzed due to not desaturating to the lowest bin (70-80%)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Masimo INVSENSOR00069 | SpO2 Accuracy of Masimo INVSENSOR00069 | 1.72 % of oxygen saturated hemoglobin |