CONNEQT Pulse Validation Study
- Conditions
- Pregnancy RelatedPre-EclampsiaGestational Hypertension
- Interventions
- Device: Blood pressure measurement
- Registration Number
- NCT06002971
- Lead Sponsor
- Mount Carmel Health System
- Brief Summary
The purpose of this study is to validate the accuracy of the CONNEQT Pulse blood pressure monitoring system for the measurement of blood pressure as compared to a gold standard, auscultatory sphygmomanometer in a pregnant population.
- Detailed Description
Clinical staff will review patient's medical record to determine eligibility. Following informed consent, a brief medical history will be collected. Serial blood pressure measurements will be collected to compare an auscultatory sphygmomanometer to blood pressure measurements of the CONNEQT Pulse blood pressure monitoring system in a pregnant population according to ISO protocol 81060-2.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pre-Eclampsia Blood pressure measurement Pre-eclampsia patients beyond the first trimester: i) with proteinuria \>300 mg in 24 h; and ii) with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg Hypertensive Blood pressure measurement Hypertensive pregnant patients beyond the first trimester: i) without proteinuria \>300 mg in 24 h; and ii) with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg Normotensive Blood pressure measurement Normotensive pregnant patients beyond the first trimester with systolic blood pressure \<140 mmHg and diastolic blood pressure \<90 mmHg
- Primary Outcome Measures
Name Time Method Comparison of reference auscultatory blood pressure readings to CONNEQT Pulse blood pressure readings. Up to 60 minutes Paired means and standard deviations of both systolic and diastolic blood pressure readings will be analyzed according to section 5.2.4.1.2 of ISO 81060-2 protocol.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mount Carmel East
🇺🇸Columbus, Ohio, United States