Data Collection for Validation of an NIBP Algorithm in Pregnant Women

NCT05789849 | Unknown FDA Device

• 1 other identifier: 219397851
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Collection of per procedure and device log files.

  Start of blood pressure acquisition until three valid pairs obtained, approximately one hour

Other Outcomes (1)

• Number of Safety Events and Device Issues

  Start of blood pressure acquisition until three valid pairs obtained, approximately one hour

Study Arms (1)

Blood Pressure Collection

EXPERIMENTAL

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

Interventions

Collecting blood pressure measurements with noninvasive blood pressure device 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.

Also known as: GE DINAMAP® SuperSTAT algorithm

Blood Pressure Collection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

GEHC Patient Care Solutions Research Program Integrator

CONTACT

+1-262-290-6037; meghan.terry@ge.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open label, single-site, single arm, prospective, pivotal study including a training phase and a data collection phase.

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: September 14, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)