Data Collection for Validation of an NIBP Algorithm in Pregnant Women

NCT ID: NCT05789849

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-14
• Study Completion Date: 2023-09-30

Brief Summary

The purpose of the study is to collect per subject blood pressure data on the device's intended population as described in the International Organization for Standardization (ISO) Standard 81060-2:2018+A1:2020 Non-invasive sphygmomanometers.

Detailed Description

The purpose of the study is to collect data per subject NIBP measurements by (1) oscillometric means using the GE NIBP Auscultatory Algorithm and (2) by conventional auscultatory means in a pregnant population. These measurements include Systolic BP (mmHg) and Diastolic BP (mmHg). The secondary objective of this study is to collect per procedure and log files from the device. The safety objective of this study is to collect safety information, including type and number of adverse events, serious adverse events and device issues.

This is an open label, single-site, single arm, prospective, pivotal study including a training phase and a validation phase with demographics-based stratification quota. Subjects are sequentially tested with investigational and reference blood pressure measurements.

Conditions

Blood Pressure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Blood Pressure Collection

This study has only 1 arm; investigational NIBP measurements will be collected using a NIBP Auscultatory Algorithm with alternating NIBP measurements collected using a reference sphygmomanometer.

Group Type: EXPERIMENTAL

Collecting blood pressure measurements with noninvasive blood pressure device

Intervention Type: DEVICE

Noninvasive blood pressure measurements will collected based on the recommendations of the International Organization for Standardization (ISO) 81060-2:2018+A1:2020 Non-invasive sphygmomanometers -Clinical investigation of intermittent automated measurement type. This study has only 1 arm; investigational NIBP measurements will be collected using a NIBP Auscultatory Algorithm with alternating NIBP measurements collected using a reference sphygmomanometer.

Interventions

Collecting blood pressure measurements with noninvasive blood pressure device

Noninvasive blood pressure measurements will collected based on the recommendations of the International Organization for Standardization (ISO) 81060-2:2018+A1:2020 Non-invasive sphygmomanometers -Clinical investigation of intermittent automated measurement type. This study has only 1 arm; investigational NIBP measurements will be collected using a NIBP Auscultatory Algorithm with alternating NIBP measurements collected using a reference sphygmomanometer.

Intervention Type: DEVICE

Other Intervention Names

GE DINAMAP® SuperSTAT algorithm

Eligibility Criteria

Inclusion Criteria

Are pregnant female volunteers aged 18 years or older;

Gestation beyond the first trimester as evidenced by gestational age of greater than or equal to 14 weeks and 0 days;

Have compatible anatomy to fit a standard air-filled occlusive cuff size (an upper limb circumference ranging 17 cm to 40 cm);

Are willing and able to volunteer to provide multiple blood pressure measurements as required for study procedures;

Are able and willing to provide written informed consent.

Exclusion Criteria

Exhibit signs or symptoms or have a current diagnosis of peripheral vascular disease;

Have current, uncontrolled circulatory shock or cardiac arrhythmias that pose risk to the patient or could interfere with completion of study blood pressure determinations;

Exhibit injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the investigator, may prevent proper occlusive cuff application or functioning; the investigator, may prevent proper occlusive cuff application or functioning;

Have contraindications to blood pressure measurement methods used in the study or any medical condition where study procedures could pose a risk to the subject/patient's physiological stability, in the opinion of a medically qualified investigator.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nandini Raghuraman, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Maternal-Fetal Medicine Washington University in St Louis School of Medicine

Adithya Bhat, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University in St. Louis

St Louis, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

GEHC Patient Care Solutions Research Program Integrator

Role: CONTACT

meghan.terry@ge.com

+1-262-290-6037

Facility Contacts

Tracey Huitt

Role: primary

tabell@wustl.edu

314-747-2198

Other Identifiers

219397851

Identifier Type: -

Identifier Source: org_study_id