Clinical Calibration & Validation of a Next-Generation Blood Pressure Monitor for Patient Management (CCV)

Comparison, Calibration, and Validation of the Non-invasive Cloud DX Pulsewave Health MonitorTM With Direct Invasive Radial and Central Arterial Measurements During Cardiac Catheterization

The objective of the Cloud DX Pulsewave Health Monitor study is to prospectively calibrate and validate a novel, non-invasive wrist cuff blood pressure device against the gold standard for hemodynamic monitoring (intra-arterial pressure) in voluntarily consented patient participants who are scheduled for an elective cardiac catheterization procedure for clinically valid reasons.

Study Overview

• Status: Completed
• Conditions: Hypertension

Detailed Description

The Cloud DX Pulsewave Health Monitor is a non-invasive wrist cuff blood pressure device that is licensed by Health Canada with Food and Drug Administration approval. Systolic and diastolic pressures are measured via the arterial pulse waveform of the left radial artery. Initially, the blood pressure algorithm was created and calibrated using the auscultatory method. The purpose of this study is to calibrate the device to the clinical gold standard of peripheral and central intra-arterial pressures.

The device acquires a pulse signal in real-time, stores signal and measurement data, and displays stored signal and measurement data for interpretation via internet servers where it is accessible by end-users (physicians and/or patients). The system provides secure accounts for both in-patient and out-patient monitoring. Cloud DX's Pulsewave Health Monitor servers are housed in a secure data center. Privacy measures are to SSAE16 SOC-1 Type-II compliance: 1) restricted secure access, 2) dedicated firewall, 3) HTTPS channel communication via website, 4) self-encrypting hard-drives rendered useless if removed from the server.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Canada
  • New Brunswick
    • Saint John, New Brunswick, Canada
      • Horizon Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for an elective, non-emergent cardiac catheterization with right radial access; exclusion criteria being no history of peripheral vascular disease, no previous coronary artery bypass graft, no precious percutaneous coronary intervention, abdominal aortic aneurysm, arrhythmia, hand/body tremor, nor bilateral arm pressure inequality during history and physical.

Description

Inclusion Criteria:

• ≥ 19 years of age
• Patients recommended by their cardiologist for a first-time, elective cardiac catheterization procedure
• Wrist circumference between 13.5cm - 23cm (5.3 - 9.1in.)
• Bilateral arm blood pressure equality (systolic within ±10mmHg; diastolic within ±5mmHg) on 2 separate readings (Nurse Associate & TRA)
• Willing to volunteer to participate and to sign the study specific informed consent form

Exclusion Criteria:

• No history of peripheral vascular disease, no previous percutaneous coronary intervention, nor previous coronary artery bypass graft
• No arrhythmia
• No abdominal aortic aneurysm
• No hand/body tremor

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Pressure	Central aortic pressure (mmHg)	Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter measurements on day of cardiac catheterization procedure.
Diastolic Pressure	Central aortic pressure (mm Hg)	Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter measurements on day of cardiac catheterization procedure.
Systolic Pressure	Peripheral arterial pressure (mm Hg)	Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.
Diastolic Pressure	Peripheral arterial pressure (mm Hg)	Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.

Collaborators and Investigators

• Sponsor: Cardiovascular Research New Brunswick
• Collaborators: Dalhousie University; Horizon Health Network; Cloud DX Inc.; New Brunswick Health Research Foundation
• Investigators: Principal Investigator: Sohrab Lutchmedial, MD, FRCPC, Cardiovascular Research New Brunswick

Publications and helpful links

General Publications

• Melville S, Teskey R, Philip S, Simpson JA, Lutchmedial S, Brunt KR. A Comparison and Calibration of a Wrist-Worn Blood Pressure Monitor for Patient Management: Assessing the Reliability of Innovative Blood Pressure Devices. J Med Internet Res. 2018 Apr 25;20(4):e111. doi: 10.2196/jmir.8009.

Helpful Links

• Device company website

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: January 5, 2017
• First Submitted That Met QC Criteria: January 9, 2017
• First Posted (Estimate): January 10, 2017

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Hypertension; Telemonitoring; Vital signs
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: RS#: 2013-1919

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided