Clinical trial NCT04869826: Calibration of a Wrist Cuff Blood Pressure Device, According to the AAMI/ESH/ISO Universal Standard
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Keywords: Hypertension
Blood pressure
Telemedicine
Telemonitoring
Vital sign monitoring
Lead sponsor: Cardiovascular Research New Brunswick
Sponsor class: OTHER
Collaborators: name: Cloud DX Inc.
name: Horizon Health Network
name: New Brunswick Health Research Foundation
name: Dalhousie University
First posted: 2021-05-03
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Systolic Pressure
timeFrame: From the start of cuff inflation to the end of cuff deflation (approximately 60 seconds)
measure: Systolic Pressure
timeFrame: 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)
measure: Diastolic Pressure
timeFrame: From the start of cuff inflation to the end of cuff deflation (approximately 60 seconds)
measure: Diastolic Pressure
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Saint John
country: Canada
facility: Horizon Health Network
Study officials:
affiliation: Complicated Hypertension Clinic, Saint John Regional Hospital
name: Martin MacKinnon, MD, FRCP(C)
role: PRINCIPAL_INVESTIGATOR
References: