Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03986281
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Marc Gillinov, MD, The Cleveland Clinic

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.


Condition or disease Intervention/treatment Phase
Hypertension Cardiac Disease Surgery Other: Omron Wearable Device Other: Standard Arterial Line Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Pilot Study to Assess the Accuracy of Blood Pressure Assessment by the Omron HeartGuide Smartwatch
Actual Study Start Date : May 20, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Accuracy of the Omron blood pressure sensor [ Time Frame: 24 hours ]
    Omron device accuracy as compared to arterial line BP readings



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986281


Contacts
Layout table for location contacts
Contact: Marc Gillinov, M. D. 216-444-2480 GILLINOM@ccf.org

Locations
Layout table for location information
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Marc Gillinov, MD    216-445-8841    Gillinom@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Layout table for investigator information
Principal Investigator: Marc Gillinov, M. D. The Cleveland Clinic

Publications:
Layout table for additonal information
Responsible Party: Marc Gillinov, MD, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03986281     History of Changes
Other Study ID Numbers: 19-319
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marc Gillinov, MD, The Cleveland Clinic:
Wearable devices
Blood pressure
Arterial line
Hypertension
Post Operative
Cardiac Surgery

Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Heart Diseases
Vascular Diseases
Cardiovascular Diseases