Data Collection for Validation of an NIBP Algorithm in Pregnant Women

Data Collection for Validation of a Noninvasive Blood Pressure Auscultatory Algorithm - Pregnant Women

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.

Study Overview

• Status: Recruiting
• Conditions: Blood Pressure
• Intervention / Treatment: Device: Collecting blood pressure measurements with noninvasive blood pressure device

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.

• Study Type: Interventional
• Enrollment (Anticipated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: GEHC Patient Care Solutions Research Program Integrator; Phone Number: +1-262-290-6037; Email: meghan.terry@ge.com

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University in St. Louis
      • Contact: Tracey Huitt; Phone Number: 314-747-2198; Email: tabell@wustl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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.; Other Names: GE DINAMAP® SuperSTAT algorithm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection of per subject NIBP measurements	The primary objective of this study is to collect per subject NIBP measurements by oscillometric means using the GE NIBP Auscultatory Algorithm and by conventional auscultatory means in a pregnant population. These measurements include both Systolic BP (mmHg) and Diastolic BP (mmHg).	Start of blood pressure acquisition until three valid pairs obtained, approximately one hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection of per procedure and device log files.	The secondary objective of this study is to collect per procedure and device log files.	Start of blood pressure acquisition until three valid pairs obtained, approximately one hour

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Safety Events and Device Issues	The safety objective of this study is to collect safety information, including type and number of adverse events, serious adverse events, and device issues.	Start of blood pressure acquisition until three valid pairs obtained, approximately one hour

Collaborators and Investigators

• Sponsor: GE Healthcare
• Investigators: Principal Investigator: Nandini Raghuraman, MD, Division of Maternal-Fetal Medicine Washington University in St Louis School of Medicine; Principal Investigator: Adithya Bhat, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: March 16, 2023
• First Posted (Actual): March 29, 2023

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 219397851

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes