Clinical Performance of Masimo INVSENSOR00057 for Heart Rate Measurements
Not Applicable
Completed
- Conditions
- Healthy
- Registration Number
- NCT05462886
- Lead Sponsor
- Masimo Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Masimo Corporation
🇺🇸Irvine, California, United States
Masimo Corporation🇺🇸Irvine, California, United States