CONNEQT Pulse Validation Study

Pregnancy Related Clinical Trial

Official title:

Validation of the CONNEQT Blood Pressure Monitoring System in a Pregnant Patient Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06002971
• Other study ID #: 230608-6
• Status: Recruiting
• Start date: August 21, 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Mount Carmel Health System
• Contact: Robin L Driver, BS
• Phone: (614) 620-6590
• Email: rdriver[@]mchs.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Eclampsia
• Gestational Hypertension
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia
• Pregnancy Related

Intervention

Device:
• Blood pressure measurement
Serial blood pressure measurements to compare reference auscultatory sphygmomanometer to CONNEQT Pulse according to ISO 81060-2.

Locations

Country	Name	City	State
United States	Mount Carmel East	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Mount Carmel Health System	AtCor Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 60 minutes