Healthy
Conditions
Brief summary
This study is designed to compare the accuracy of a noninvasive measurement of heart rate compared to reference values obtained by a standard of care ECG monitor.
Interventions
DEVICEMasimo INVSENSOR00057
Noninvasive wearable health monitoring device
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is 18 to 80 years of age. * Subject is able to read and communicate in English.
Exclusion criteria
* Subject has open wounds, inflamed tattoos or piercings on the area of device placement, and/or has any visible healing wounds that the investigator and/or medical professional determines may place them at an increased risk for participation. * Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate Accuracy of Masimo INVSENSOR00057 | 1-3 hours | Heart rate accuracy was determined by calculating the accuracy root mean-squared (Arms) difference between the measured values from Masimo INVSENSOR00057 (TestHR\_i) to the reference ECG monitor values (RefHR\_i). Arms= √(∑(i=1 to n) ((TestHR\_i-RefHR\_i )\^2 ))/n |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Masimo INVSENSOR00057 All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00057 device.
Masimo INVSENSOR00057: noninvasive wearable health monitoring device | 79 |
| Total | 79 |
Baseline characteristics
| Characteristic | Masimo INVSENSOR00057 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 79 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 21 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 24 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 79 participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 86 |
| other Total, other adverse events | 0 / 86 |
| serious Total, serious adverse events | 0 / 86 |
Outcome results
Primary
Heart Rate Accuracy of Masimo INVSENSOR00057
Heart rate accuracy was determined by calculating the accuracy root mean-squared (Arms) difference between the measured values from Masimo INVSENSOR00057 (TestHR\_i) to the reference ECG monitor values (RefHR\_i). Arms= √(∑(i=1 to n) ((TestHR\_i-RefHR\_i )\^2 ))/n
Time frame: 1-3 hours
Population: 17 subjects not included in analysis due to data collection error.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INVSENSOR00057 | Heart Rate Accuracy of Masimo INVSENSOR00057 | 1.38 bpm |