A Pilot Study to Assess the Accuracy of Blood Pressure Assessment by the Omron HeartGuide Smartwatch
1 other identifier
interventional
56
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hypertension
Started May 2019
Shorter than P25 for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 20, 2019
CompletedFirst Submitted
Initial submission to the registry
June 12, 2019
CompletedFirst Posted
Study publicly available on registry
June 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2019
CompletedDecember 11, 2019
December 1, 2019
7 months
June 12, 2019
December 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Accuracy of the Omron blood pressure sensor
Omron device accuracy as compared to arterial line BP readings
24 hours
Study Arms (2)
Omron HeartGuide Smartwatch
ACTIVE COMPARATORReadings from the Omron HeartGuide Smartwatch
Arterial Line
ACTIVE COMPARATORReadings from the arterial line
Interventions
Omron wearable device compared to arterial line readings
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Wrist size range smaller than 16 cm or larger than 19 cm
- Use of a radial artery graft for coronary artery bypass grafting
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Related Publications (1)
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.
PMID: 30803128BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Gillinov, M. D.
The Cleveland Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 12, 2019
First Posted
June 14, 2019
Study Start
May 20, 2019
Primary Completion
December 10, 2019
Study Completion
December 10, 2019
Last Updated
December 11, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share