CONNEQT Pulse Validation Study

Sponsor

Mount Carmel Health System (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06002971

Collaborator

AtCor Medical, Inc. (Industry)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Related Pre-Eclampsia Gestational Hypertension	Device: Blood pressure measurement

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

45 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Normotensive Normotensive pregnant patients beyond the first trimester with systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg	Device: Blood pressure measurement Serial blood pressure measurements to compare reference auscultatory sphygmomanometer to CONNEQT Pulse according to ISO 81060-2.
Hypertensive 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	Device: Blood pressure measurement Serial blood pressure measurements to compare reference auscultatory sphygmomanometer to CONNEQT Pulse according to ISO 81060-2.
Pre-Eclampsia 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	Device: Blood pressure measurement Serial blood pressure measurements to compare reference auscultatory sphygmomanometer to CONNEQT Pulse according to ISO 81060-2.

Arm

Intervention/Treatment

Normotensive

Normotensive pregnant patients beyond the first trimester with systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg

Device: Blood pressure measurement

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

Hypertensive

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

Device: Blood pressure measurement

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

Pre-Eclampsia

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

Device: Blood pressure measurement

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

All Groups:

Able to provide informed consent
Pregnant patient, beyond the first trimester (greater than 12 weeks of gestation)
18 years of age, or older

Normotensive:

Systolic blood pressure <140 mmHg (18,66 kPa) and diastolic blood pressure <90 mmHg (12 kPa)

Hypertensive:

Without proteinuria >300 mg in 24 h; and
With systolic blood pressure ≥140 mmHg (18,66 kPa) or diastolic blood pressure ≥ 90 mmHg (12 kPa)

Pre-Eclampsia:

With proteinuria >300 mg in 24 h; and
With systolic blood pressure ≥140 mmHg (18,66 kPa) or diastolic blood pressure ≥ 90 mmHg (12,00 kPa)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Mount Carmel Health System
AtCor Medical, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Robin Driver, Principal Investigator, Mount Carmel Health System

ClinicalTrials.gov Identifier:

NCT06002971

Other Study ID Numbers:

230608-6

First Posted:

Aug 21, 2023

Last Update Posted:

Aug 21, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Eclampsia

Pre-Eclampsia

Hypertension, Pregnancy-Induced

Study Results

No Results Posted as of Aug 21, 2023