Clinical trial NCT03015363: Clinical Calibration & Validation of a Next-Generation Blood Pressure Monitor for Patient Management
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Hypertension
Telemonitoring
Vital signs
Lead sponsor: Cardiovascular Research New Brunswick
Sponsor class: OTHER
Collaborators: name: Horizon Health Network
name: Dalhousie University
name: Cloud DX Inc.
name: New Brunswick Health Research Foundation
First posted: 2017-01-10
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Systolic Pressure
timeFrame: Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter measurements on day of cardiac catheterization procedure.
measure: Diastolic Pressure
timeFrame: Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter measurements on day of cardiac catheterization procedure.
measure: Systolic Pressure
timeFrame: Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.
measure: Diastolic Pressure
timeFrame: Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Saint John
country: Canada
facility: Horizon Health Network
state: New Brunswick
Study officials:
affiliation: Cardiovascular Research New Brunswick
name: Sohrab Lutchmedial, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.