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

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ClinicalTrials.gov Identifier: NCT04869826
Recruitment Status : Recruiting
First Posted : May 3, 2021
Last Update Posted : August 9, 2021
Sponsor:
Collaborators:
Cloud DX Inc.
Dalhousie University
Horizon Health Network
New Brunswick Health Research Foundation
Information provided by (Responsible Party):
Sohrab Lutchmedial, MD, FRCPC, Cardiovascular Research New Brunswick

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.

Condition or disease Intervention/treatment
Hypertension Device: Pulsewave Health Monitor (PAD-2A) Device

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
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)
Actual Study Start Date : June 15, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Outpatients Complicated Hypertension Clinic
This study population consists of 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 who are willing to volunteer to consent to participate in the study.
Device: Pulsewave Health Monitor (PAD-2A) 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.




Primary Outcome Measures :
  1. Systolic Pressure [ Time Frame: From the start of cuff inflation to the end of cuff deflation (approximately 60 seconds) ]
    Non-invasive Pulsewave Health Monitor (PAD-2A) wrist cuff blood pressure device (mmHg)

  2. Systolic Pressure [ Time Frame: 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) ]
    Simultaneous auscultatory blood pressure measurements by 2 trained observers

  3. Diastolic Pressure [ Time Frame: From the start of cuff inflation to the end of cuff deflation (approximately 60 seconds) ]
    Non-invasive Pulsewave Health Monitor (PAD-2A) wrist cuff blood pressure device (mmHg)

  4. Diastolic Pressure [ Time Frame: 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) ]
    Simultaneous auscultatory blood pressure measurements by 2 trained observers



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.
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.):

    • At least 20% of total participants, greater than 20.6 cm.
    • At least 20% of total participants, between 18.3 cm. & 20.6 cm.
    • At least 20% of total participants, between 15.9 cm. & 18.3 cm.
    • At least 20% of total participants, less than 15.9 cm.
    • At least 10% of total participants, greater than 21.8 cm.
    • At least 10% of total participants, less than 14.7 cm.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04869826


Contacts
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Contact: Sohrab Lutchmedial, MD, FRCP(C) 506-648-6101 sohrab.lutchmedial@horizonnb.ca
Contact: Keith R. Brunt, PhD 506-636-6974 keith.brunt@dal.ca

Locations
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Canada
Horizon Health Network Recruiting
Saint John, Canada
Sponsors and Collaborators
Cardiovascular Research New Brunswick
Cloud DX Inc.
Dalhousie University
Horizon Health Network
New Brunswick Health Research Foundation
Investigators
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Principal Investigator: Martin MacKinnon, MD, FRCP(C) Complicated Hypertension Clinic, Saint John Regional Hospital
Additional Information:
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Responsible Party: Sohrab Lutchmedial, MD, FRCPC, Co-Director of CVR-NB/ Director of the New Brunswick Heart Centre (NBHC) Cardiac Catheterization Laboratory, Cardiovascular Research New Brunswick
ClinicalTrials.gov Identifier: NCT04869826    
Other Study ID Numbers: RS#: 2021-3003; R#: 101246
STP-PW2-002 ( Other Identifier: Health Canada )
First Posted: May 3, 2021    Key Record Dates
Last Update Posted: August 9, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sohrab Lutchmedial, MD, FRCPC, Cardiovascular Research New Brunswick:
Hypertension
Blood pressure
Telemedicine
Telemonitoring
Vital sign monitoring
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases