Accuracy Assessment of an Automatic Blood Pressure Measurement Device in Adult Volunteers
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Healthy Adults Volunteers 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. |
Device: Sphygmo: Automatic Blood Pressure Monitor
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.
Device: GE Dinamap ProCare Automatic Blood Pressure Monitor
This commercially available gold standard blood pressure monitor will be used as a control to assess the accuracy of the Sphygmo device.
|
Outcome Measures
Primary Outcome Measures
- Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard. [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. [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 years of age or older
-
Willing and able to provide informed consent
Exclusion Criteria:
- Unable to provide informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rice University | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- William Marsh Rice University
Investigators
- Principal Investigator: Rebecca R Kortum, PhD, William Marsh Rice University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 14-082F-A
- 51262
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Healthy Adult Volunteers |
|---|---|
| Arm/Group Description | Men and women over the age of 18 who will have their blood pressure measured using both the experimental blood pressure monitor (Sphygmo), and the gold-standard, commercial blood pressure monitor (GE Dinamap ProCare). |
| Period Title: Overall Study | |
| STARTED | 85 |
| COMPLETED | 81 |
| NOT COMPLETED | 4 |
Baseline Characteristics
| Arm/Group Title | Adults Volunteers |
|---|---|
| Arm/Group Description | Men and women over the age of 18 Sphygmo: Automatic Blood Pressure Monitor: 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. |
| Overall Participants | 85 |
| Age (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
50
|
| Sex: Female, Male (Count of Participants) | |
| Female |
65
76.5%
|
| Male |
20
23.5%
|
| Region of Enrollment (participants) [Number] | |
| United States |
85
100%
|
Outcome Measures
| Title | Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard. |
|---|---|
| Description | Mean difference of systolic and diastolic blood pressure readings between Sphygmo device and 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Healthy Adult Volunteers |
|---|---|
| Arm/Group Description | Men and women over the age of 18 who had their blood pressure measured using both the experimental device (Sphygmo) as well as the commercial, gold-standard monitor (GE Dinamap ProCare). |
| Measure Participants | 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)
|
| Title | Percentage of Sphygmo Readings That Were With < 5 mmHg, < 10 mmHg, and < 15 mmHg of the Readings by the Gold Standard Sphygmomanometer. |
|---|---|
| Description | 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. |
| 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Adults Volunteers |
|---|---|
| Arm/Group Description | Men and women over the age of 18 who will have their blood pressure measured using both the experimental blood pressure monitor (Sphygmo), and the gold-standard, commercial blood pressure monitor (GE Dinamap ProCare). |
| Measure Participants | 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
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Adults Volunteers | |
| Arm/Group Description | Men and women over the age of 18 Sphygmo: Automatic Blood Pressure Monitor: 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. | |
All Cause Mortality |
||
| Adults Volunteers | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Adults Volunteers | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/85 (1.2%) | |
| Cardiac disorders | ||
| High Blood Pressure | 1/85 (1.2%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Adults Volunteers | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/85 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Rebecca Richards-Kortum |
|---|---|
| Organization | Rice 360: Institute for Global Health |
| Phone | 713-348-3823 |
| rkortum@rice.edu |
- 14-082F-A
- 51262