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

Completed

• Conditions: Hypertension

• Registration Number: NCT03015363
• Lead Sponsor: Cardiovascular Research New Brunswick

Brief Summary

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.

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 Timeline

• Study Start: 2013-11
• Primary Completion: 2016-05
• Study First Submitted: 2017-01-05
• Study First Submitted QC: 2017-01-09
• Study First Posted: 2017-01-10
• Study Completion: 2018-12
• Status Verified: 2021-08
• Results First Submitted: 2021-08-03
• Results First Submitted QC: 2021-08-03
• Last Update Submitted: 2021-08-03
• Results First Posted: 2021-08-30
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Systolic Pressure	Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.	Peripheral arterial pressure (mm Hg)
Diastolic Pressure	Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.	Peripheral arterial pressure (mm Hg)

Trial Locations

Locations (1)

Horizon Health Network; 🇨🇦 Saint John, New Brunswick, Canada