Trial Outcomes & Findings for Pilot Assessment of an Auto Blood Pressure Monitor (NCT NCT02258256)

NCT ID: NCT02258256

Last Updated: 2021-08-10

Results Overview

Mean systolic and diastolic pressures measured by the Sphygmo device blood pressure measurement and the commercially available device. Measurements were taken multiple times over the course of 24-72 hours at intervals determined by the supervising clinician. Mean blood pressure for each participant was measured using each device and compared between the two devices (Sphygmo minus Standard). The reported values represent the mean systolic and diastolic blood pressures measured by Sphygmo vs Gold Standard device, averaged across all participants

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: Measured during a single study visit, up to 24-72 hours.
• Results posted on: 2021-08-10

Participant Flow

Participant milestones

Measure	Preeclamptic Women All subjects are pre-eclamptic women who will have their 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 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
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Assessment of an Auto Blood Pressure Monitor

Baseline characteristics by cohort

Measure	Preeclamptic Women n=11 Participants All subjects are pre-eclamptic women who will have their 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 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	28 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Malawi	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured during a single study visit, up to 24-72 hours.

Mean systolic and diastolic pressures measured by the Sphygmo device blood pressure measurement and the commercially available device. Measurements were taken multiple times over the course of 24-72 hours at intervals determined by the supervising clinician. Mean blood pressure for each participant was measured using each device and compared between the two devices (Sphygmo minus Standard). The reported values represent the mean systolic and diastolic blood pressures measured by Sphygmo vs Gold Standard device, averaged across all participants

Outcome measures

Measure	Preeclamptic Women n=11 Participants All subjects are pre-eclamptic women who will have their 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 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
Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard. Systolic Mean BP - Sphygmo	125.3 mmHg Standard Deviation 31.8
Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard. Mean Diastolic BP - Sphygmo	85.2 mmHg Standard Deviation 29.8
Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard. Mean Systolic BP - GE Dinamap	129.8 mmHg Standard Deviation 24.8
Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard. Mean Diastolic BP - GE Dinamap	76.9 mmHg Standard Deviation 17.0

Adverse Events

Preeclamptic Women

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: rkortum@rice.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place