Blood Pressure, Blood Pressure Monitoring
Conditions
Keywords
Blood pressure validation
Brief summary
The purpose of this study is to test how accurately the Perin Health Patch, a small wearable sensor worn on the chest, measures blood pressure without using an arm cuff. Adults 22 to 90 years of age wore the patch while trained observers took blood pressure readings at the same time using a standard arm cuff and stethoscope. The patch readings were then compared to the standard readings to see how closely they match, following recognized international testing standards for blood pressure devices (ISO 81060-2 and IEEE 1708). Participants visited one of three study sites up to three times over about one week. At the final visit, participants also did light resistance band exercise to briefly raise their blood pressure and relaxation activities to lower it, so the patch could be tested while blood pressure was changing.
Interventions
DEVICEChest Worn Blood Pressure Monitor
The Perin Health Patch (PHP) is an investigational, battery powered, wearable physiological monitoring device with an adhesive patch and sensor module, applied to the upper left chest. Cuffless noninvasive blood pressure measurements from the device were compared to a reference sphygmomanometer (dual observer auscultation, same arm simultaneous method).
Sponsors
Perin Health Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant must have the ability to read and understand English and provide written informed consent. * Participant must be willing and able to comply with study procedures and duration. * Participant is an adult 22 - 90 years of age. * Participant must have an arm circumference in the range of the reference and calibration cuffs.
Exclusion criteria
* Participant is unwilling to provide informed consent. * Participants with deformities or abnormalities that may prevent proper application of the DUT * Female participants who self-reported as pregnant, or who are self-reported as trying to get pregnant. * Participants with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, or other sensors (self-reported) * Participant's screening BP exceed Measurement Range of the device (Systolic: 80-230 mmHg, Diastolic: 40-130 mm Hg) * Participants with known heart arrhythmias. * Participants with peripheral vascular disease. * Participants with clotting disorders. * History of bleeding disorders or personal history of prolonged bleeding from injury * History of blood clots * Hemophilia * Participants that cannot tolerate sitting or standing for the duration of the study. * Participant with a blood pressure demographic that has already been filled. * Other known health conditions that will prevent safe participation in the study upon disclosure in health assessment form or verbally. * Participant is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Accuracy During Induced Blood Pressure Change | Day 7 (final study visit) | Mean error and standard deviation (mmHg) of paired determinations between the device under test and the reference sphygmomanometer during induced blood pressure increase (isometric resistance band exercise) and induced blood pressure decrease (relaxation) procedures, evaluated per IEEE 1708:2014 (including Amendment 1, 2019) and ISO 81060-2:2018/AMD 1:2020. |
| Standard Deviation of Averaged Paired Determinations Per Participant (ISO 81060-2 Criterion 2) | Day 1 through Day 7 (visit window up to Day 9 per participant) | Standard deviation (mmHg) of the averaged paired determinations per participant, calculated separately for systolic and diastolic blood pressure per ISO 81060-2:2018/AMD 1:2020. Acceptance criterion: the standard deviation must not exceed the maximum permissible standard deviation as a function of the observed mean error, per Table 1 (Averaged subject data acceptance) of the standard. |
| Mean Error of Paired Blood Pressure Determinations (ISO 81060-2 Criterion 1) | Day 1 through Day 7 (visit window up to Day 9 per participant) | Mean error (mmHg) of the individual paired determinations between the device under test and the reference sphygmomanometer (dual observer auscultation, same arm simultaneous method), calculated separately for systolic and diastolic blood pressure across all participants per ISO 81060-2:2018/AMD 1:2020. Acceptance criterion: mean error ≤ ±5.0 mmHg. |
| Standard Deviation of the Error of Paired Blood Pressure Determinations (ISO 81060-2 Criterion 1) | Day 1 through Day 7 (visit window up to Day 9 per participant) | Standard deviation (mmHg) of the errors of the individual paired determinations between the device under test and the reference sphygmomanometer, calculated separately for systolic and diastolic blood pressure across all participants per ISO 81060-2:2018/AMD 1:2020. Acceptance criterion: standard deviation ≤ 8.0 mmHg. |
Countries
United States
Outcome results
None listed