NCT05976425

ModPG3 Neo-Infant ISO 81060-2:2018

ModPG3 Blood Pressure Device for Neo-Infants

• Status: Terminated
• Phase: —
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Welch Allyn · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Accepted

Summary

Automated blood pressure cuff measurements taken by an "oscillometric device" is the standard in numerous medical settings today. Studies show that oscillometric devices using algorithms are more accurate and consistent than devices using other non-invasive measuring techniques, especially in critical cases. SureBP algorithm estimates BP during cuff inflation; the second, StepBP algorithm does so during deflation. The purpose of this study is to test the algorithms contained in the ModPG3 on Neonate and Infants subjects to determine if they meet the requirements of ISO 81060-2:2018/Amd 1:2020 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type

Conditions

• Blood Pressure

Interventions

Type	Name	Description
DEVICE	ModPG3 Investigational Device	* Connex Vital Sign Monitor with ModPG3 * Laptop * Data Collection Software * USB cable * Power strip * Welch Allyn FlexiPort Disposable Blood Pressure Cuffs
DEVICE	Invasive Reference Equipment	* Surveyor S12/S19 * Hill-Rom ICU Medical data collection cable DIR 60119852 * Hill-Rom Edwards data collection cable DIR 60119853

Timeline

• Start date: 2024-02-23
• Primary completion: 2025-04-29
• Completion: 2025-04-29
• First posted: 2023-08-04
• Last updated: 2026-02-23
• Results posted: 2026-02-23

Locations

1 site across 1 country: United States