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| ID | Type | Description | Link |
|---|---|---|---|
| STP-PW2-002 | Other Identifier | Health Canada |
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| Name | Class |
|---|---|
| Cloud DX Inc. | INDUSTRY |
| Horizon Health Network | OTHER |
| New Brunswick Health Research Foundation | OTHER |
| Dalhousie University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outpatients Complicated Hypertension Clinic | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsewave Health Monitor (PAD-2A) Device | Device | 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. |
| 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) |
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Inclusion Criteria:
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:
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For this study, we will recruit and consent approximately 200 adult male and female patient participants (≥ 19 years of age; minimum 30% male/female) who are referred to the Complicated Hypertension Clinic at the Saint John Regional Hospital (SJRH) and non-patient participants who are willing to volunteer to consent to participate in the study. Eligibility of participants for this study is based on the inclusion and exclusion criteria as per the ISO 81060-2: AMD_2020 protocol, as described below.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christie Aguiar, PhD | Contact | 506-977-2712 | christie.aguiar@CloudDX.com | |
| Keith R. Brunt, PhD | Contact | 506-636-6974 | keith.brunt@dal.ca |
| Name | Affiliation | Role |
|---|---|---|
| Martin MacKinnon, MD, FRCP(C) | Complicated Hypertension Clinic, Saint John Regional Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Horizon Health Network | Recruiting | Saint John | Canada |
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| Label | URL |
|---|---|
| Cloud DX device company website. | View source |
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Currently, the clinical research group is undecided regarding individual participant data (IDP) sharing with other researchers upon completion of this study, although it is acknowledged that the practice of data sharing among scientists, clinicians, and other professionals is of increasing importance, particularly for transparency in clinical research studies.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
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