CONNEQT Pulse Validation Study

Mount Carmel Health System41 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Interventions

Blood pressure measurementDEVICE

Serial blood pressure measurements to compare reference auscultatory sphygmomanometer to CONNEQT Pulse according to ISO 81060-2.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

All Groups: 1. Able to provide informed consent 2. Pregnant patient, beyond the first trimester (greater than 12 weeks of gestation) 3. 18 years of age, or older Normotensive: 1\. Systolic blood pressure \<140 mmHg (18,66 kPa) and diastolic blood pressure \<90 mmHg (12 kPa) Hypertensive: 1. Without proteinuria \>300 mg in 24 h; and 2. With systolic blood pressure ≥140 mmHg (18,66 kPa) or diastolic blood pressure ≥ 90 mmHg (12 kPa) Pre-Eclampsia: 1. With proteinuria \>300 mg in 24 h; and 2. With systolic blood pressure ≥140 mmHg (18,66 kPa) or diastolic blood pressure ≥ 90 mmHg (12,00 kPa)

Locations (1)

Mount Carmel East

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Comparison of reference auscultatory blood pressure readings to CONNEQT Pulse blood pressure readings.

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.

Time frame: Up to 60 minutes

Data from ClinicalTrials.gov

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