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

NCT03986281 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2019-12-11

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Omron Wearable Device

Omron wearable device compared to arterial line readings

OTHER

Standard Arterial Line

Omron wearable device compared to arterial line readings

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Marc Gillinov, M. D. · The Cleveland Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-20
Primary Completion
2019-12-10
Completion
2019-12-10

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03986281 on ClinicalTrials.gov