Trial Outcomes & Findings for Accuracy Assessment of an Automatic Blood Pressure Measurement Device in Pregnant Women (NCT NCT02319174)

Results Overview

Mean difference of systolic and diastolic blood pressures between Sphygmo blood pressure measurements and measurements from the gold standard sphygmomanometer.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

43 participants

Primary outcome timeframe

Blood pressure was measured an average of 9 times for each participant and the average of these measurements was recorded. Each measurement period lasted approximately 30-45 minutes

Results posted on

2018-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	Sphygmo All subjects will have blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device. All subjects are pregnant women. Sphygmo: A team of engineers from Rice University 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 Study STARTED	43
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Accuracy Assessment of an Automatic Blood Pressure Measurement Device in Pregnant Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sphygmo n=42 Participants All subjects will have blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device. All subjects are pregnant women. Sphygmo: 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	29 years n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood pressure was measured an average of 9 times for each participant and the average of these measurements was recorded. Each measurement period lasted approximately 30-45 minutes

Population: Of 41 participants who completed the study, 5 participants were excluded on account of the observer reporting a difficulty in hearing, movement, or uncertainty with the measurement. This left 36 participants, 18 of which were used to train the device. The data presented here is from the remaining 18 participants.

Mean difference of systolic and diastolic blood pressures between Sphygmo blood pressure measurements and measurements from the gold standard sphygmomanometer.

Outcome measures

Outcome measures
Measure	Sphygmo n=18 Participants All subjects will have blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device. All subjects are pregnant women. Sphygmo: 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	Dinamap n=18 Participants All subjects will have blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device. All subjects are pregnant women. Dinamap: Dinamap is a commercially available, ambulatory, blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals
Accuracy of Blood Pressure Readings by Sphygmo Systolic Mean	114.5 mmHg Standard Deviation 10.9	115.6 mmHg Standard Deviation 12.5
Accuracy of Blood Pressure Readings by Sphygmo Diastolic Mean	65.7 mmHg Standard Deviation 8.3	66.3 mmHg Standard Deviation 10.6

PRIMARY outcome

Timeframe: Blood pressure was measured an average of 9 times for each participant during their single measurement period, and the average of those measurements was recorded. Each measurement period lasted approximately 30-45 minutes

Population: Of 41 participants who completed the study, 5 participants were excluded on account of the observer reporting a difficulty in hearing, movement, or uncertainty with the measurement. This left 36 participants, 18 of which were used to train the device. The data presented here is from the remaining 18 participants.

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 (A/A) with the validation data from this study.

Outcome measures

Outcome measures
Measure	Sphygmo n=18 Participants All subjects will have blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device. All subjects are pregnant women. Sphygmo: 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	Dinamap All subjects will have blood pressure measured by both the research device (Sphygmo) and the commercially available device. All clinical decisions will be made using measurements from the commercially available device. All subjects are pregnant women. Dinamap: Dinamap is a commercially available, ambulatory, blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals
Percent of Sphygmo Readings That Were Within 5mmHg, 10mmHg, and 15mmHg of the Readings by the Gold Standard Sphygmomanometer. Systolic Difference <5 mmHg	67 percentage of measurements in range	—
Percent of Sphygmo Readings That Were Within 5mmHg, 10mmHg, and 15mmHg of the Readings by the Gold Standard Sphygmomanometer. Systolic Difference <10 mmHg	85 percentage of measurements in range	—
Percent of Sphygmo Readings That Were Within 5mmHg, 10mmHg, and 15mmHg of the Readings by the Gold Standard Sphygmomanometer. Systolic Difference <15 mmHg	98 percentage of measurements in range	—
Percent of Sphygmo Readings That Were Within 5mmHg, 10mmHg, and 15mmHg of the Readings by the Gold Standard Sphygmomanometer. Diastolic Difference <5 mmHg	70 percentage of measurements in range	—
Percent of Sphygmo Readings That Were Within 5mmHg, 10mmHg, and 15mmHg of the Readings by the Gold Standard Sphygmomanometer. Diastolic Difference <10 mmHg	89 percentage of measurements in range	—
Percent of Sphygmo Readings That Were Within 5mmHg, 10mmHg, and 15mmHg of the Readings by the Gold Standard Sphygmomanometer. Diastolic Difference <15 mmHg	98 percentage of measurements in range	—

Adverse Events

Sphygmo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

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