NCT05789849

Data Collection for Validation of an NIBP Algorithm in Pregnant Women

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: GE Healthcare · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-14
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2023-03-29
• Last updated: 2023-03-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study