CONNEQT Pulse Validation Study

Last updated: October 24, 2023
Sponsor: Mount Carmel Health System
Overall Status: Active - Recruiting

Phase

N/A

Condition

High Blood Pressure (Hypertension - Pediatric)

Pregnancy Complications

Treatment

Blood pressure measurement

Clinical Study ID

NCT06002971
230608-6
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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)

Study Design

Total Participants: 45
Treatment Group(s): 1
Primary Treatment: Blood pressure measurement
Phase:
Study Start date:
August 21, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Mount Carmel East

    Columbus, Ohio 43213
    United States

    Active - Recruiting

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