ModPG3 Neo-Infant ISO 81060-2:2018
NCT05976425 · Status: TERMINATED · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2026-02-23
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
- 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
Sponsors & Collaborators
-
Welch Allyn
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Max Age
- 3 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-02-23
- Primary Completion
- 2025-04-29
- Completion
- 2025-04-29
Countries
- United States
Study Locations
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