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

• Sponsor: William Marsh Rice University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02319174
• Collaborator: The University of Texas Health Science Center, Houston (Other)
• Enrollment: 43
• Location: 1
• Arm: 1
• Duration (Months): 17.1
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

The purpose of the study is to help make a lower cost automatic blood pressure monitor device for diagnosis and monitoring of pre-eclampsia in pregnant women, where automatic blood pressure monitoring is limited or not available. The study will compare this low cost device to a commercially available system used for pre-eclamptic women in many United States hospitals that the investigators will be bringing to Malawi as a part of this study.

The team hopes to show that this lower cost blood pressure machine works well and can help women with pre-eclampsia. The study also aims to see if this machine is easy for the nurse to use.

70 pregnant women who are either at-risk or diagnosed with pre-eclampsia will be enrolled at University of Texas Health Science Center Houston. Patient arm circumference will be measured with measurement tape.

They will be seated upright in a comfortable chair with arm at heart level and an arm blood pressure cuff from either the automatic blood pressure monitor or a manual sphygmomanometer will be placed on the left arm.

The cuff will be inflated and then deflated until measurement concludes. Heart rate will be measured with tactile arterial palpation.The process will be repeated for a total of up to nine measurements, alternating between measurements with the automatic blood pressure monitor and the manual sphygmomanometer. There will be a waiting period of 45-60 seconds between each measurement.

The results of this study will help researchers understand the performance and usability of this device in Malawi and help decide if any design changes are needed.

Condition or Disease	Intervention/Treatment	Phase
Pre Eclampsia	Device: Sphygmo	N/A

Detailed Description

The research team has developed an automatic blood pressure monitor to be used for the monitoring and diagnosis of pre-eclampsia in pregnant women, particularly in low-resource settings where current monitoring is limited. This study aims to evaluate the accuracy of the device's blood pressure measurements in pregnant and pre-eclamptic women. This device must be evaluated with the above described population because blood pressure measurement devices are known to perform differently in pregnant and pre-eclamptic women than in normal healthy adults.

This study will take place at the University of Texas Health Science Center (UTHSC) where up to 70 subjects will be recruited to participate during their regularly scheduled antenatal care checkups.

1. The Patient arm circumference will be measured with measurement tape.

2. The Patient will be seated upright in a comfortable chair with arm at heart level.

3. An arm blood pressure cuff from either the automatic blood pressure monitor or a manual sphygmomanometer will be placed on the left arm of the patient over the brachial artery.

4. Cuff will be inflated to ~200 mmHg and then deflated until measurement concludes.

5. Heart rate will be measured with Tactile Arterial Palpation.

6. Steps 3-4 will be repeated for a total of up to nine measurements, alternating between measurements with the automatic blood pressure monitor and the manual sphygmomanometer. There will be a waiting period of 45-60 seconds between each measurement.

Study Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Accuracy Assessment of an Automatic Blood Pressure Measurement Device in Pregnant Women
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Nov 4, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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

Outcome Measures

Primary Outcome Measures

1. Accuracy of Blood Pressure Readings by Sphygmo [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]

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

2. Percent of Sphygmo Readings That Were Within 5mmHg, 10mmHg, and 15mmHg of the Readings by the Gold Standard Sphygmomanometer. [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]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Pregnant women receiving antenatal care at the UT OB/GYN clinic.

• Over the age of 18

Exclusion Criteria:

• Women under the age of 18

• Women unable to provide informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Health Science Center Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

• William Marsh Rice University
• The University of Texas Health Science Center, Houston

Investigators

• Principal Investigator: Rebecca R Kortum, PhD, William Marsh Rice University

Study Documents (Full-Text)

None provided.

More Information

Publications

• De Greeff A, Ghosh D, Anthony J, Shennan A. Accuracy assessment of the Dinamap ProCare 400 in pregnancy and preeclampsia. Hypertens Pregnancy. 2010 Jan;29(2):198-205. doi: 10.3109/10641950902968650.
• Dekker G, Sibai B. Primary, secondary, and tertiary prevention of pre-eclampsia. Lancet. 2001 Jan 20;357(9251):209-15. Review.
• Magee LA, Abalos E, von Dadelszen P, Sibai B, Easterling T, Walkinshaw S; CHIPS Study Group. How to manage hypertension in pregnancy effectively. Br J Clin Pharmacol. 2011 Sep;72(3):394-401. doi: 10.1111/j.1365-2125.2011.04002.x. Review.
• Natarajan P, Shennan AH, Penny J, Halligan AW, de Swiet M, Anthony J. Comparison of auscultatory and oscillometric automated blood pressure monitors in the setting of preeclampsia. Am J Obstet Gynecol. 1999 Nov;181(5 Pt 1):1203-10.
• O'Brien E, Petrie J, Littler W, de Swiet M, Padfield PL, Altman DG, Bland M, Coats A, Atkins N. An outline of the revised British Hypertension Society protocol for the evaluation of blood pressure measuring devices. J Hypertens. 1993 Jun;11(6):677-9.
• Turner JA. Diagnosis and management of pre-eclampsia: an update. Int J Womens Health. 2010 Sep 30;2:327-37. doi: 10.2147/IJWH.S8550.

• Responsible Party: Rebecca Richards-Kortum, Stanley C. Moore Professor of Bioengineering, William Marsh Rice University
• ClinicalTrials.gov Identifier: NCT02319174
• Other Study ID Numbers: 14-082F-B
• First Posted: Dec 18, 2014
• Last Update Posted: Dec 19, 2018
• Last Verified: Dec 1, 2018

• Additional relevant MeSH terms: Eclampsia; Pre-Eclampsia

Study Results

Participant Flow

Arm/Group Title	Sphygmo
Arm/Group Description	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
Period Title: Overall Study
STARTED	43
COMPLETED	42
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Sphygmo
Arm/Group Description	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
Overall Participants	42
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	29
Sex: Female, Male (Count of Participants)
Female	42 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	42 100%

Outcome Measures

1. Primary Outcome

Title	Accuracy of Blood Pressure Readings by Sphygmo
Description	Mean difference of systolic and diastolic blood pressures between Sphygmo blood pressure measurements and measurements from the gold standard sphygmomanometer.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Sphygmo	Dinamap
Arm/Group Description	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	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
Measure Participants	18	18
Systolic Mean	114.5 (10.9)	115.6 (12.5)
Diastolic Mean	65.7 (8.3)	66.3 (10.6)

2. Primary Outcome

Title	Percent of Sphygmo Readings That Were Within 5mmHg, 10mmHg, and 15mmHg 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 (A/A) with the validation data from this study.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Sphygmo
Arm/Group Description	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
Measure Participants	18
Systolic Difference <5 mmHg	67
Systolic Difference <10 mmHg	85
Systolic Difference <15 mmHg	98
Diastolic Difference <5 mmHg	70
Diastolic Difference <10 mmHg	89
Diastolic Difference <15 mmHg	98

Adverse Events

Time Frame	1 year and 5 months.
Arm/Group Title	Sphygmo
Arm/Group Description	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
All Cause Mortality
	Sphygmo
	Affected / at Risk (%)	# Events
Total	0/43 (0%)
Serious Adverse Events
	Sphygmo
	Affected / at Risk (%)	# Events
Total	0/43 (0%)
Other (Not Including Serious) Adverse Events
	Sphygmo
	Affected / at Risk (%)	# Events
Total	0/43 (0%)

Limitations/Caveats

[Not Specified]

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.