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

Hypertension Clinical Trial

— CCV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03015363
• Other study ID #: RS#: 2013-1919
• Status: Completed
• Start date: November 2013
• Est. completion date: December 2018

Study information

• Verified date: August 2021
• Source: Cardiovascular Research New Brunswick
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2018
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Locations

Country	Name	City	State
Canada	Horizon Health Network	Saint John	New Brunswick

Sponsors (5)

Lead Sponsor	Collaborator
Cardiovascular Research New Brunswick	Cloud DX Inc., Dalhousie University, Horizon Health Network, New Brunswick Health Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	Systolic Pressure	Peripheral arterial pressure (mm Hg)	Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.
Primary	Diastolic Pressure	Peripheral arterial pressure (mm Hg)	Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.

External Links

•   Device company website