Calibration of a Wrist Cuff Blood Pressure Device, According to the AAMI/ESH/ISO Universal Standard

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to calibrate the blood pressure measurements of the Pulsewave Health Monitor (PAD-2A) device to be within 5±8 mmHg of the average of the dual-observer measurements via an aneroid sphygmomanometer (reference device), as per the methodology described in the ISO 81060-2: AMD_2020 protocol.

Detailed Description
-----------------
The plan for this study is to calibrate the blood pressure measurements of the PAD-2A device with the dual-observer blood pressure measurements via an aneroid sphygmomanometer (reference device), as per the ISO 81060-2: AMD_2020 protocol. The data will be collected and analyzed in order to calibrate the PAD-2A device blood pressure measurements to be within 5±8 mmHg of the average of the dual-observer auscultatory blood pressure measurements by adjusting the device algorithm.

Official Title
-----------------
Calibration of the Cloud DX Pulsewave Health Monitor (PAD-2A) Oscillometric Wrist Cuff Home Blood Pressure Monitor, According to the AAMI/ESH/ISO Universal Standard (ISO 81060-2: AMD_2020) (CCV-4)

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Device: Pulsewave Health Monitor (PAD-2A) Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults ≥ 19 years of age (minimum 30% male/female) Wrist circumference between 13.5 cm. - 23 cm. (5.3 in. - 9.1 in.): Specifically for this test device, the wrist size of the consented participants will be distributed accordingly for a Gaussian distribution: Lowest Octile: ≥ 13.5cm to < 14.7cm Lower Quarter: ≥ 13.5cm to < 15.9cm Lower-Middle Quarter: ≥ 15.9cm to < 18.3cm Upper-Middle Quarter: ≥ 18.3cm to < 20.7cm Upper Quarter: ≥ 20.7cm to ≤ 23.0cm Highest Octile: ≥ 21.9cm to ≤ 23.0cm ● Willing to volunteer to participate and to sign the study specific informed consent form Exclusion Criteria: Wrist circumference less than 13.5 cm. (5.3 in.) or greater than 23 cm. (9.1 in) Hand or body tremors Irregular heart rhythm (bigeminy, trigeminy, isolated ventricular premature beat (VPB), atrial fibrillation) Korotkoff sound K5 not audible Pregnant A musculoskeletal disorder that prevents a non-invasive device to be inflated/deflated on the arm Unwilling to volunteer to participate and to sign the study specific informed consent form

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Outpatients Complicated Hypertension Clinic<br>This study population consists of approximately 200 adult male and female participants (≥ 19 years of age; minimum 30% male/female). Participants will be recruited from eligible patients who are referred to the Complicated Hypertension Clinic at the Saint John Regional Hospital (SJRH) as well as non-patient participants who are willing to volunteer to consent to participate in the study. | Device: Pulsewave Health Monitor (PAD-2A) Device<br>* This is an observational, comparison study of blood pressure measurements. The objective of this study is to calibrate the blood pressure measurements of the Pulsewave Health Monitor (PAD-2A) device to be within 5±8 mmHg of the average of the dual-observer auscultatory blood pressure measurements via an aneroid sphygmomanometer (reference device), as per the ISO 81060-2: AMD_2020 universal protocol.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Pressure | Non-invasive Pulsewave Health Monitor (PAD-2A) wrist cuff blood pressure device (mmHg) | From the start of cuff inflation to the end of cuff deflation (approximately 60 seconds) | 
| Systolic Pressure | Simultaneous auscultatory blood pressure measurements by 2 trained observers | From the start of manual inflation of the upper arm blood pressure cuff to the end of (manual) deflation of the upper arm blood pressure cuff (approximately 30-60 seconds) | 
| Diastolic Pressure | Non-invasive Pulsewave Health Monitor (PAD-2A) wrist cuff blood pressure device (mmHg) | From the start of cuff inflation to the end of cuff deflation (approximately 60 seconds) | 
| Diastolic Pressure | Simultaneous auscultatory blood pressure measurements by 2 trained observers | From the start of manual inflation of the upper arm blood pressure cuff to the end of (manual) deflation of the upper arm blood pressure cuff (approximately 30-60 seconds) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Blood pressure, Telemedicine, Telemonitoring, Vital sign monitoring