Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2018-08-01
2019-10-01
Brief Summary
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Detailed Description
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The wrist-worn measurement device is intended to be worn on the wrist for intermittent measurements of Blood pressure.
The use does not require any special action from the user apart from wearing the band on either their left or right wrist. The device applies no inflatable mechanics or moving parts. The wristband is watertight and can be worn as any type of bracelet all the time or most of the time.
The study will include subjects that are hospitalized in the ICU and/or any of the cardiology departments or affiliating units such as Cath lab, heart transplant unit, etc..) and are continually monitored by an intra-arterial blood pressure line (A-line). A medical professional will measure simultaneous non-invasive auscultatory readings to determine the lateral difference for later adjustment of calculation. A medical professional or a company representative accompanied by a medical professional will place the device on the opposite limb than the one having the A-line, providing the location of the placement has intact skin. During the measurement stage, BP values are simultaneously recorded from the reference invasive A-line and the wrist worn device.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Primary Objective
Evaluation of the devices accuracy referenced to interventional (A-line) measurement.
Wrist-worn measurement device (LiveMetric)
Evaluation of the wrist-worn measurement devices accuracy referenced to interventional (A-line) measurements.
Interventions
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Wrist-worn measurement device (LiveMetric)
Evaluation of the wrist-worn measurement devices accuracy referenced to interventional (A-line) measurements.
Eligibility Criteria
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Inclusion Criteria
* Patients that are ≥18 years of age.
Exclusion Criteria
* Subjects without normal palpable radial artery pulse, whether congenital, due to medical intervention, or otherwise
* Subjects with wrist circumference less than 155mm or greater than 210mm
* Subjects implanted with pacemaker, VAD's or other mechanical circulatory support device whether intracorporeal or extracorporeal
* Patients that do not have an intra-arterial blood pressure line.
18 Years
ALL
No
Sponsors
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LiveMetric S.A.
OTHER
Responsible Party
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Principal Investigators
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Gabriel Sayer, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago
Chicago, Illinois, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
NYU School of Medicine
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Esther Vorovich, MD
Role: primary
Greta Piper, MD
Role: primary
References
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Sayer G, Piper G, Vorovich E, Raikhelkar J, Kim GH, Rodgers D, Shimbo D, Uriel N. Continuous Monitoring of Blood Pressure Using a Wrist-Worn Cuffless Device. Am J Hypertens. 2022 May 10;35(5):407-413. doi: 10.1093/ajh/hpac020.
Other Identifiers
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IRB18-1281
Identifier Type: -
Identifier Source: org_study_id
NCT03911349
Identifier Type: -
Identifier Source: nct_alias
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