A Pilot Study to Assess the Accuracy of Blood Pressure Assessment by the Omron HeartGuide Smartwatch

The accuracy of devices like the recent FDA-clearance of the Omron HeartGuide™ Blood Pressure sensor in robust clinical settings remain in question and thus form the underpinning of this research study.

The objective of this pilot prospective study is to assess the accuracy of the Omron Blood Pressure sensor as compared to arterial line blood pressure monitoring.

Study Overview

• Status: Completed
• Conditions: Hypertension; Surgery; Cardiac Disease
• Intervention / Treatment: Other: Omron Wearable Device; Other: Standard Arterial Line

Detailed Description

The purpose of this study is to assess the accuracy of the Omron HeartGuide™ Smartwatch in measuring blood pressure and heart rate as compared to standard post-operative blood pressure and heart rate monitoring with an arterial line and heart monitor.

Hypertension affects about 75 million Americans and is the leading cause of cardiovascular disease (heart attacks and strokes), resulting in about 1,000 deaths per day. Only 50% of patients have their blood pressure adequately managed thus necessitating a better solution. Current limitations to hypertension management in non-ICU or non-surgical settings include: 1) infrequent measurements, 2) inherent data variability, 3) white coat hypertension, 4) non-compliance, or 5) poor patient-provider follow-up. A majority of patients have their blood pressure measured only during clinic visits. A wearable blood pressure sensor that takes multiple measurements per day will allow for a new level of granularity among measurements. With more continuous measurements, patients and physicians can work together to identify the onset and progression of hypertension before it causes irreversible damage to the heart, kidneys, and brain.

During testing, each subject will wear the Omron HeartGuide™ Smartwatch. Both right and left wrist circumferences will be measured prior to placing the device. All patients will be on continuous telemetry according to standard clinical practice on the ICU. Each patient will be outfitted with the Omron HeartGuide™ Smartwatch (opposite extremity of the arterial line). An Omron BP reading will be obtained at the same time as the arterial line reading. Four readings in total will be obtained for each patient. All four readings may occur on the same day or may be occur over several days.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age > 18 years
• Post-operative cardiac surgery patients on the ICU floors at the Cleveland Clinic Main Campus
• Wrist size range ranging from 16 cm to 19 cm

Exclusion Criteria:

• Wrist size range smaller than 16 cm or larger than 19 cm
• Use of a radial artery graft for coronary artery bypass grafting

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Omron HeartGuide Smartwatch; Readings from the Omron HeartGuide Smartwatch	Other: Omron Wearable Device; Omron wearable device compared to arterial line readings
Active Comparator: Arterial Line; Readings from the arterial line	Other: Standard Arterial Line; Omron wearable device compared to arterial line readings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of the Omron blood pressure sensor	Omron device accuracy as compared to arterial line BP readings	24 hours

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Marc Gillinov, M. D., The Cleveland Clinic

Publications and helpful links

General Publications

• Kuwabara M, Harada K, Hishiki Y, Kario K. Validation of two watch-type wearable blood pressure monitors according to the ANSI/AAMI/ISO81060-2:2013 guidelines: Omron HEM-6410T-ZM and HEM-6410T-ZL. J Clin Hypertens (Greenwich). 2019 Jun;21(6):853-858. doi: 10.1111/jch.13499. Epub 2019 Feb 25.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): December 10, 2019
• Study Completion (Actual): December 10, 2019

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 12, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Hypertension; Post Operative; Cardiac Surgery; Blood pressure; Wearable devices; Arterial line
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Heart Diseases; Hypertension
• Other Study ID Numbers: 19-319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No