Blood PressureNCT03919136
Wrist Worn Blood Pressure Measurement
An observational study of Blood Pressure and Heart Failure, run by LiveMetric S.A. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure, Heart Failure, Advanced Heart Failure
- What is being tested?
- Wrist-worn measurement device (LiveMetric)
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2018to 1 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an arterial line used for continuous blood pressure monitoring.
Who may be able to join
- Patients who have a pre-existing intra-arterial blood pressure (A-Line) line for standard care
- Patients that are ≥18 years of age.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 606037
Gabriel Sayer, MD, 773-702-9396, gsayer@medicine.bsd.uchicago.edu
Daniel E Rodgers, 773-702-9396, drodgers3@medicine.bsd.uchicago.edu
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Esther Vorovich, MD
- Recruiting
NYU School of Medicine
New York, New York, 10016
Greta Piper, MD
About this study
Official title: Accuracy of Non-Invasive Non-Oscillometric Blood Pressure Wrist Worn Measurement
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.
Read the 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.
- Being tested
- Wrist-worn measurement device (LiveMetric)
- Keywords
- Heart Failure, Advanced Heart Failure, Blood Pressure, High Blood Pressure, Low Blood Pressure
- Medical subject headings
- Heart Failure, Hypertension, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrist-worn measurement device (LiveMetric)Device
Evaluation of the wrist-worn measurement devices accuracy referenced to interventional (A-line) measurements.
| Study group | Role | What they receive |
|---|---|---|
| Primary Objective | Evaluation of the devices accuracy referenced to interventional (A-line) measurement. Receives: Device: Wrist-worn measurement device (LiveMetric) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start1 Aug 2018
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LiveMetric S.A.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel Sayer, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919136
- Sponsor's protocol ID
- IRB18-1281
- Status last verified
- Apr 2019
- First submitted
- 15 Apr 2019
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35171213
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Non-Invasive Non-Oscillometric Blood Pressure Wrist Worn Measurement
- ClinicalTrials.gov ID
- NCT03919136
- Acronym / sponsor ID
- IRB18-1281
- Keywords
- Heart Failure, Advanced Heart Failure, Blood Pressure, High Blood Pressure, Low Blood Pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- LiveMetric S.A.University, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 18 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Objective | – | Device: Wrist-worn measurement device (LiveMetric)Evaluation of the devices accuracy referenced to interventional (A-line) measurement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an arterial line used for continuous blood pressure monitoring.
Key inclusion criteria (2 listed)
- Patients who have a pre-existing intra-arterial blood pressure (A-Line) line for standard care
- Patients that are ≥18 years of age.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wrist-worn measurement device (LiveMetric)Evaluation of the wrist-worn measurement devices accuracy referenced to interventional (A-line) measurements. | Device | Primary Objective |
Primary outcome
Non-Oscillometric Blood Pressure Wrist Worn Data Acquisition and Analysis
Time frame: 2 years
Measurements including systolic and diastolic pressures will be assessed and analyzed retrospectively according to the requirements of the standard (ISO 81060-2).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Derived from this study: PubMed 35171213Sayer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel Sayer, MD principal investigator
University of Chicago
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure and Heart Failure, run by LiveMetric S.A. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriel Sayer, MD (773-702-9396, gsayer@medicine.bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-Oscillometric Blood Pressure Wrist Worn Data Acquisition and Analysis (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03919136, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.