Trial Outcomes & Findings for Accuracy Assessment of an Automatic Blood Pressure Measurement Device in Adult Volunteers (NCT NCT02267577)

Results Overview

Mean difference of systolic and diastolic blood pressure readings between Sphygmo device and the gold standard sphygmomanometer.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

90 participants

Primary outcome timeframe

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.

Results posted on

2020-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Adult Volunteers 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).
Overall Study STARTED	85
Overall Study COMPLETED	81
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adults Volunteers n=85 Participants 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.
Age, Continuous	50 years n=93 Participants
Sex: Female, Male Female	65 Participants n=93 Participants
Sex: Female, Male Male	20 Participants n=93 Participants
Region of Enrollment United States	85 participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

Population: 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.

Mean difference of systolic and diastolic blood pressure readings between Sphygmo device and the gold standard sphygmomanometer.

Outcome measures

Outcome measures
Measure	Healthy Adult Volunteers n=72 Participants 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).
Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard. Mean Systolic BP - Sphygmo	122.5 mmHg Standard Deviation 14.9
Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard. Mean Diastolic BP Difference - Sphygmo	74.5 mmHg Standard Deviation 11.1
Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard. Mean Systolic BP - GE Dinamap	123.1 mmHg Standard Deviation 17.7
Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard. Mean Diastolic BP - GE Dinamap	72.1 mmHg Standard Deviation 12.6

PRIMARY outcome

Timeframe: 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.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Healthy Adult Volunteers n=72 Participants 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).
Percentage of Sphygmo Readings That Were With < 5 mmHg, < 10 mmHg, and < 15 mmHg of the Readings by the Gold Standard Sphygmomanometer. Diastolic Difference <10 mmHg	77 percentage of measurements in that range
Percentage of Sphygmo Readings That Were With < 5 mmHg, < 10 mmHg, and < 15 mmHg of the Readings by the Gold Standard Sphygmomanometer. Diastolic Difference <15 mmHg	90 percentage of measurements in that range
Percentage of Sphygmo Readings That Were With < 5 mmHg, < 10 mmHg, and < 15 mmHg of the Readings by the Gold Standard Sphygmomanometer. Systolic Difference <5 mmHg	56 percentage of measurements in that range
Percentage of Sphygmo Readings That Were With < 5 mmHg, < 10 mmHg, and < 15 mmHg of the Readings by the Gold Standard Sphygmomanometer. Systolic Difference <10 mmHg	79 percentage of measurements in that range
Percentage of Sphygmo Readings That Were With < 5 mmHg, < 10 mmHg, and < 15 mmHg of the Readings by the Gold Standard Sphygmomanometer. Systolic Difference <15 mmHg	92 percentage of measurements in that range
Percentage of Sphygmo Readings That Were With < 5 mmHg, < 10 mmHg, and < 15 mmHg of the Readings by the Gold Standard Sphygmomanometer. Diastolic Difference <5 mmHg	53 percentage of measurements in that range

Adverse Events

Adults Volunteers

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Adults Volunteers n=85 participants at risk 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.
Cardiac disorders High Blood Pressure	1.2% 1/85 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rebecca Richards-Kortum

Rice 360: Institute for Global Health

Phone: 713-348-3823

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place