Wrist Worn Blood Pressure Measurement
Accuracy of Non-Invasive Non-Oscillometric Blood Pressure Wrist Worn Measurement
1 other identifier
observational
40
1 country
3
Brief Summary
In this study, the investigators are testing the accuracy of a wrist-worn measurement device by comparing its blood pressure measurement to arterial line (A-line) blood pressure monitors. The device is similar in style and fit to popular activity bands, but it is unique in that it measures blood pressure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2018
3 active sites
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
August 1, 2018
CompletedFirst Submitted
Initial submission to the registry
April 15, 2019
CompletedFirst Posted
Study publicly available on registry
April 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedApril 19, 2019
April 1, 2019
1.2 years
April 15, 2019
April 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Non-Oscillometric Blood Pressure Wrist Worn Data Acquisition and Analysis
Measurements including systolic and diastolic pressures will be assessed and analyzed retrospectively according to the requirements of the standard (ISO 81060-2).
2 years
Study Arms (1)
Primary Objective
Evaluation of the devices accuracy referenced to interventional (A-line) measurement.
Interventions
Evaluation of the wrist-worn measurement devices accuracy referenced to interventional (A-line) measurements.
Eligibility Criteria
Patients with an arterial line used for continuous blood pressure monitoring.
You may qualify if:
- Patients who have a pre-existing intra-arterial blood pressure (A-Line) line for standard care
- Patients that are ≥18 years of age.
You may not qualify if:
- Body habitus that precludes patients from wearing a device on their wrist
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LiveMetric S.A.lead
Study Sites (3)
University of Chicago
Chicago, Illinois, 606037, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
NYU School of Medicine
New York, New York, 10016, United States
Related Publications (1)
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.
PMID: 35171213DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriel Sayer, MD
University of Chicago
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2019
First Posted
April 18, 2019
Study Start
August 1, 2018
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
April 19, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share