ModPG3 Neo-Infant ISO 81060

Not Applicable

Recruiting

• Conditions: Blood Pressure
• Interventions: Device: ModPG3 Investigational Device; Device: Invasive Reference Equipment

• Registration Number: NCT05976425
• Lead Sponsor: Baxter Healthcare Corporation

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-28
• Study First Submitted QC: 2023-07-28
• Study First Posted: 2023-08-04
• Study Start: 2024-02-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-07
• Primary Completion: 2025-05
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood pressure readings	ModPG3 Investigational Device	Using the data acquisition software provided, a reading for the subject will be started. The tool will automatically record the pre invasive blood pressure readings, then take the NIBP measurement with the device under test, and it will follow up with a post invasive blood pressure reading.
Blood pressure readings	Invasive Reference Equipment	Using the data acquisition software provided, a reading for the subject will be started. The tool will automatically record the pre invasive blood pressure readings, then take the NIBP measurement with the device under test, and it will follow up with a post invasive blood pressure reading.

Primary Outcome Measures

Name	Time	Method
Compliance of the ModPG3 blood pressure (BP) readings with ISO Requirements	Day 1 (up to one hour)	Data shall be analyzed according to the formulas called out in section 6.2.6 of ISO 81060-2:2018/Amd 1:2020.

Trial Locations

Locations (2)

East Carolina University; 🇺🇸 Greenville, North Carolina, United States

Azienda Ospedaliero - Universitaria Meyer; 🇮🇹 Firenze, Italy