Pre EclampsiaNCT02267577

Accuracy Assessment of an Automatic Blood Pressure Measurement Device in Adult Volunteers

A study testing Sphygmo: Automatic Blood Pressure Monitor and GE Dinamap ProCare Automatic Blood Pressure Monitor in people with Pre Eclampsia, run by William Marsh Rice University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The research team has developed an automatic blood pressure monitor (Sphygmo) to be used for the monitoring and diagnosis of pre-eclampsia in pregnant women, particularly in low-resource settings where current monitoring is limited. 90 adult volunteers will be enrolled by researchers at Rice University. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Pre Eclampsia
What is being tested?: Sphygmo: Automatic Blood Pressure Monitor and GE Dinamap ProCare Automatic Blood Pressure Monitor
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteUnited States
Study dates: Jan 2015to 12 Oct 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

18 years of age or older
Willing and able to provide informed consent

Who cannot join

Unable to provide informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

Rice University
Houston, Texas, 77030

Other trials in United States

About this study

90 adult volunteers will be enrolled by researchers at Rice University. The participant will be seated in a comfortable chair with arm at heart level. Arm circumference will be measured and a blood pressure cuff will be placed on the arm. The cuff will be inflated and blood pressure measurements will be taken by a commercially available device and by the Sphygmo device. Blood pressure measurements from both devices will be recorded. The participant's blood pressure will be measured up to 9 times with a waiting period of 45-60 seconds between each measurement.

The results of this study will be used to optimize the blood pressure detection algorithm and thus further develop the device.

Conditions: Pre Eclampsia
Being tested: Sphygmo: Automatic Blood Pressure Monitor, GE Dinamap ProCare Automatic Blood Pressure Monitor
Medical subject headings: Pre-Eclampsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sphygmo: Automatic Blood Pressure MonitorDevice
A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals.
GE Dinamap ProCare Automatic Blood Pressure MonitorDevice
This commercially available gold standard blood pressure monitor will be used as a control to assess the accuracy of the Sphygmo device.

Study groups in NCT02267577
Study group	Role	What they receive
Healthy Adults Volunteers	Experimental	Men and women over the age of 18 will have their blood pressure measured with both the Sphygmo: Automatic Blood Pressure Monitor device and the GE Dinamap ProCare automatic blood pressure monitor. Receives: Device: Sphygmo: Automatic Blood Pressure Monitor; Device: GE Dinamap ProCare Automatic Blood Pressure Monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard.
Mean difference of systolic and diastolic blood pressure readings between Sphygmo device and the gold standard sphygmomanometer.
Measured: Blood pressure was measured an average of 9 times for each participant during their single visit and the mean of these measurements was recorded and used for analysis. The measurement period lasted approximately 30-45 minutes.
Percentage of Sphygmo Readings That Were With < 5 mmHg, < 10 mmHg, and < 15 mmHg of the Readings by the Gold Standard Sphygmomanometer.
The British Hypertension society defines a specific criteria for the accuracy of a sphygmomanometer. Devices are graded according to the cumulative percentage of readings that have an absolute difference between the more favorable observer's mercury sphygmomanometer readings and the test device of < 5 mmHg, < 10 mmHg, and < 15 mmHg. A letter grade of "A" requires that over 60%, 85%, and 95% were achieved in the < 5 mmHg, < 10 mmHg, and <15 mmHg categories, respectively. A letter grade of "B" requires that over 50%, 75%, and 90% were achieved in the < 5 mmHg, < 10 mmHg, and <15 mmHg categories, respectively. The test device achieved a grade of (B/B) with the validation data from this study.
Measured: Blood pressure was measured an average of 9 times for each participant during their single visit and the mean of these measurements was recorded and used for analysis. The measurement period lasted approximately 30-45 minutes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201512 Oct 2017

First posted17 Oct 2014 (estimated)
Study startJan 2015
Primary completionOct 2015
Study completion12 Oct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pre EclampsiaStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Model description: Participants enrolled in the study will have their blood pressure measured multiple times with both the GE Dinamap Procare commercial blood pressure monitor and Sphygmo, the experimental blood pressure monitoring device.
Masking: None (open label)
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02267577
Sponsor's protocol ID: 14-082F-A
Other IDs: 51262
Status last verified: Mar 2020
First submitted: 9 Oct 2014
Last updated: 6 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
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Molecular Study of the Maternal-fetal Interface in Preeclampsia.
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Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
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RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia

All Pre Eclampsia trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Accuracy Assessment of an Automatic Blood Pressure Measurement Device in Adult Volunteers
ClinicalTrials.gov ID: NCT02267577
Acronym / sponsor ID: 14-082F-A
Conditions: Pre Eclampsia
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: William Marsh Rice UniversityUniversity, hospital or other
Study start: Jan 2015
Primary completion: Oct 2015 (actual)
Study completion: 12 Oct 2017 (actual)
First posted: 17 Oct 2014 (estimated)
Results: Posted 15 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The results of this study will be used to optimize the blood pressure detection algorithm and thus further develop the device.

Study design

Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Participants enrolled in the study will have their blood pressure measured multiple times with both the GE Dinamap Procare commercial blood pressure monitor and Sphygmo, the experimental blood pressure monitoring device.

Arm	Type	Receives
Healthy Adults Volunteers	Experimental	Device: Sphygmo: Automatic Blood Pressure Monitor, Device: GE Dinamap ProCare Automatic Blood Pressure MonitorMen and women over the age of 18 will have their blood pressure measured with both the Sphygmo: Automatic Blood Pressure Monitor device and the GE Dinamap ProCare automatic blood pressure monitor.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

18 years of age or older
Willing and able to provide informed consent

Key exclusion criteria (1 listed)

Unable to provide informed consent

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
Sphygmo: Automatic Blood Pressure MonitorA team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals.	Device	Healthy Adults Volunteers
GE Dinamap ProCare Automatic Blood Pressure MonitorThis commercially available gold standard blood pressure monitor will be used as a control to assess the accuracy of the Sphygmo device.	Device	Healthy Adults Volunteers

Primary outcome

Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard.
Time frame: Blood pressure was measured an average of 9 times for each participant during their single visit and the mean of these measurements was recorded and used for analysis. The measurement period lasted approximately 30-45 minutes.
Mean difference of systolic and diastolic blood pressure readings between Sphygmo device and the gold standard sphygmomanometer.
Percentage of Sphygmo Readings That Were With < 5 mmHg, < 10 mmHg, and < 15 mmHg of the Readings by the Gold Standard Sphygmomanometer.
Time frame: Blood pressure was measured an average of 9 times for each participant during their single visit and the mean of these measurements was recorded and used for analysis. The measurement period lasted approximately 30-45 minutes.
The British Hypertension society defines a specific criteria for the accuracy of a sphygmomanometer. Devices are graded according to the cumulative percentage of readings that have an absolute difference between the more favorable observer's mercury sphygmomanometer readings and the test device of < 5 mmHg, < 10 mmHg, and < 15 mmHg. A letter grade of "A" requires that over 60%, 85%, and 95% were achieved in the < 5 mmHg, < 10 mmHg, and <15 mmHg categories, respectively. A letter grade of "B" requires that over 50%, 75%, and 90% were achieved in the < 5 mmHg, < 10 mmHg, and <15 mmHg categories, respectively. The test device achieved a grade of (B/B) with the validation data from this study.

Results and safety

Results posted to the registry on 15 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Adult Volunteers	85	81

Primary outcome: Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard.

Time frame: Blood pressure was measured an average of 9 times for each participant during their single visit and the mean of these measurements was recorded and used for analysis. The measurement period lasted approximately 30-45 minutes.. Mean (Standard Deviation). Unit: mmHg

Measure	Healthy Adult Volunteers n = 72
Mean Systolic BP - Sphygmo	122.5 (14.9)
Mean Diastolic BP Difference - Sphygmo	74.5 (11.1)
Mean Systolic BP - GE Dinamap	123.1 (17.7)
Mean Diastolic BP - GE Dinamap	72.1 (12.6)

Population analysed: Data from nine participants of the original 81 who completed the study was excluded on account of the observer reporting a difficulty in hearing, movement, or uncertainty with the measurement.

Primary outcome: Percentage of Sphygmo Readings That Were With < 5 mmHg, < 10 mmHg, and < 15 mmHg of the Readings by the Gold Standard Sphygmomanometer.

Measure	Adults Volunteers n = 72
Systolic Difference <5 mmHg	56
Systolic Difference <10 mmHg	79
Systolic Difference <15 mmHg	92
Diastolic Difference <5 mmHg	53
Diastolic Difference <10 mmHg	77
Diastolic Difference <15 mmHg	90

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adults Volunteers	1 of 85 (1.2%)	0 of 85 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pre Eclampsia

Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia

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.

Rebecca R Kortum, PhD principal investigator

William Marsh Rice University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 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 6 Mar 2020. 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?

Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard. (time frame: Blood pressure was measured an average of 9 times for each participant during their single visit and the mean of these measurements was recorded and used for analysis. The measurement period lasted approximately 30-45 minutes.). The study lists 2 primary outcomes in all. 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 NCT02267577.

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 6 Mar 2020.