Blood PressureNCT03566888
Validation of a Noninvasive Automated Blood Pressure Device
An observational study of Blood Pressure, run by University of Southern California at 1 site in United States.
Trial summary
The investigator's objective is to validate the novel automated blood pressure device against the requirements set forth in the AAMI_ISO 81060-2:2010 standard in voluntarily consented study participants. Read more about this study
- Who is it for?
- Ages 12 to 92 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Blood pressure assessment
- Type of treatment
- Medical device
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 2 Oct 2018
- 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 12 to 92 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals between the ages of 12-92 years, generally healthy, and have not been diagnosed with heart disease.
Who may be able to join
- between the ages of 12 to 92 years of age.
- generally healthy but can be on medication for blood pressure regulation.
Who cannot join
- heart disease is present such as, coronary artery disease, cardiomegaly, irregular heart rhythm, atrial fibrillation, heart valve disease, congenital heart disease, cardiomyopathy, pericardial effusion, Marfan syndrome, and heart murmurs.
- using a pacemaker to maintain a suitable heart rate.
- missing their natural left arm.
- exhibit a musculoskeletal disorder that may prevent them from sitting upright for a period of time (~40min) or prevent a BP reading taken from the left arm.
- Special populations, for example pregnant women and patients with known arrhythmias.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
The investigator's objective is to validate the novel automated blood pressure device against the requirements set forth in the AAMI_ISO 81060-2:2010 standard in voluntarily consented study participants.
Read the detailed description
A new prototype blood pressure cuff has been designed for the higi SH llc health stations. This new cuff accurately captures blood pressure (BP) by emulating a fitted cuff which is used in conjunction with a mercury sphygmomanometer, the accepted gold standard for measuring BP values in most clinical facilities. The cuff is driven by a motor and gearhead to automatically "wrap" the cuff around a user's arm when they initiate a BP test. A BP measurement is then taken by an Original Equipment Manufacturer (OEM) BP module using an algorithm developed for use with a fitted cuff; the same module one would expect to find in a clinic or doctor's office. For the device to pass the AAMI_ISO 81060-2:2010 standard statistical requirements and thus, be considered a valid device for measuring BP it will need to meet the standards criteria 1 and 2.
- Conditions
- Blood Pressure
- Being tested
- Blood pressure assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure assessmentDevice
Validation of an automated blood pressure device
| Study group | Role | What they receive |
|---|---|---|
| Single Group | 85 eligible study participants Receives: Device: Blood pressure assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic and Diastolic blood pressure (criteria 1 and 2)
Mean value of the differences of the paired (i.e., device under test - reference method) determinations for all study participants shall be within or equal to ± 5 mmHg with a standard deviation no greater than 8 mmHg (criterion 1). Standard deviation of the averaged paired determinations per participant shall meet the criterion 2 listed in the standard.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start1 Aug 2017
- Primary completion2 Oct 2018
- Study completion2 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Todd Schroeder, University of Southern California
- Investigators
- Todd Schroeder, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566888
- Sponsor's protocol ID
- HS-17-00139
- Status last verified
- Nov 2018
- First submitted
- 12 Jun 2018
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Noninvasive Automated Blood Pressure Device
- ClinicalTrials.gov ID
- NCT03566888
- Acronym / sponsor ID
- HS-17-00139
- Conditions
- Blood Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 2 Oct 2018 (actual)
- Study completion
- 2 Oct 2018 (actual)
- First posted
- 25 Jun 2018 (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.
The investigator's objective is to validate the novel automated blood pressure device against the requirements set forth in the AAMI_ISO 81060-2:2010 standard in voluntarily consented study participants.
Detailed description
A new prototype blood pressure cuff has been designed for the higi SH llc health stations. This new cuff accurately captures blood pressure (BP) by emulating a fitted cuff which is used in conjunction with a mercury sphygmomanometer, the accepted gold standard for measuring BP values in most clinical facilities. The cuff is driven by a motor and gearhead to automatically "wrap" the cuff around a user's arm when they initiate a BP test. A BP measurement is then taken by an Original Equipment Manufacturer (OEM) BP module using an algorithm developed for use with a fitted cuff; the same module one would expect to find in a clinic or doctor's office. For the device to pass the AAMI_ISO 81060-2:2010 standard statistical requirements and thus, be considered a valid device for measuring BP it will need to meet the standards criteria 1 and 2.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group | – | Device: Blood pressure assessment85 eligible study participants |
Who may qualify
- Ages
- 12 to 92 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals between the ages of 12-92 years, generally healthy, and have not been diagnosed with heart disease.
Key inclusion criteria (2 listed)
- between the ages of 12 to 92 years of age.
- generally healthy but can be on medication for blood pressure regulation.
Key exclusion criteria (5 listed)
- heart disease is present such as, coronary artery disease, cardiomegaly, irregular heart rhythm, atrial fibrillation, heart valve disease, congenital heart disease, cardiomyopathy, pericardial effusion, Marfan syndrome, and heart murmurs.
- using a pacemaker to maintain a suitable heart rate.
- missing their natural left arm.
- exhibit a musculoskeletal disorder that may prevent them from sitting upright for a period of time (~40min) or prevent a BP reading taken from the left arm.
- Special populations, for example pregnant women and patients with known arrhythmias.
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 |
|---|---|---|
| Blood pressure assessmentValidation of an automated blood pressure device | Device | Single Group |
Primary outcome
Systolic and Diastolic blood pressure (criteria 1 and 2)
Time frame: 60 minutes
Mean value of the differences of the paired (i.e., device under test - reference method) determinations for all study participants shall be within or equal to ± 5 mmHg with a standard deviation no greater than 8 mmHg (criterion 1). Standard deviation of the averaged paired determinations per participant shall meet the criterion 2 listed in the standard.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- 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.
Todd Schroeder, PhD principal investigator
University of Southern California
1 site 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, run by University of Southern California at 1 site 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: finished, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic and Diastolic blood pressure (criteria 1 and 2) (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2018.