Clinical trial NCT03919136: Wrist Worn Blood Pressure Measurement
Official title: Accuracy of Non-Invasive Non-Oscillometric Blood Pressure Wrist Worn Measurement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Pressure
Heart Failure
Advanced Heart Failure
Heart Failure，Congestive
Keywords: Heart Failure
Advanced Heart Failure
Blood Pressure
High Blood Pressure
Low Blood Pressure
Lead sponsor: LiveMetric S.A.
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with an arterial line used for continuous blood pressure monitoring.

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.

Detailed description: LiveMetric has developed a wrist-worn measurement device intended for use as a standalone device, designed for measurement of intermittent blood pressure for individuals suffering from hypertension or other conditions where monitoring of blood pressure is of importance.

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.

Eligibility criteria: Inclusion Criteria:

* Patients who have a pre-existing intra-arterial blood pressure (A-Line) line for standard care
* Patients that are ≥18 years of age.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Non-Oscillometric Blood Pressure Wrist Worn Data Acquisition and Analysis
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: New York
country: United States
facility: NYU School of Medicine
state: New York
Study officials:
affiliation: University of Chicago
name: Gabriel Sayer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.