ModPG3 Neo-Infant ISO 81060-2:2018

ModPG3 Blood Pressure Device for Neo-Infants

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

Study Overview

• Status: Terminated
• Conditions: Blood Pressure
• Intervention / Treatment: Device: ModPG3 Investigational Device; Device: Invasive Reference Equipment

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • East Carolina University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

1. Inclusion Criteria

   • Meets the neonatal or infant (less than 3 years of age) subject population.
   • The neonate and infant subjects will already have an indwelling intra-arterial line.
   • Subject's legally authorized representative must consent for the subject to participate.
   • Subject's legally authorized representative must be able to read, write, speak in English and/or Italian.
   • Subject must have an arm circumference in the range of 3.3-15.0 cm.
   • Subject must be able to have blood pressures taken on the upper extremity closest to the arterial line
   • The subject has one upper arm that is free of indwelling catheters or IV lines, shunts, oximetry sensors, dressings, etc. for attachment of a NIBP cuff.

2. Exclusion Criteria

   • Lack of Informed consent.
   • Subjects with deformities or abnormalities that may prevent proper application of the device under test.
   • Subject is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.
   • Subjects with known heart dysrhythmias or arrhythmias during the measurement period.
   • Subjects with compromised circulation or peripheral vascular disease.
   • Subjects who have had surgery or have shunts or implants in the upper extremity being tested.
   • Those who have a heart rate that is irregular for any reason other than normal fluctuations in the R-to-R interval associated with respiration.
   • Hospital System Pre-Screening NIBP: those who have a systolic and/or diastolic blood pressures difference > 12 mmHg between the hospital intra-arterial measurement and the hospital blood pressure cuff/automated vital signs monitor are excluded. The device under test cannot be used for this reading.
   • Subjects with clotting disorders or taking prescribed blood thinners.
   • Subjects with a severe contact allergy to sensors or cuff material.
   • Subjects with a history of skin fragility or breakdown, such as ecchymosis or lacerations, affecting the upper extremities that would affect the application of NIBP cuff.
   • Subjects whose arm circumference does not fall within 3.3 and 15.0 cm.
   • Arterial line is not properly damped.
   • The subject has an unstable condition in which NIBP cannot be obtained.
   • Subjects who have radial or brachial arterial lines.
   • Subjects who require sedation solely for the purpose of this study and/or prolonged sedation from a prior procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood Pressure Readings; 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance of the ModPG3 Blood Pressure (BP) Readings With ISO Requirements	Data shall be analyzed according to the formulas called out in section 6.2.6 of ISO 81060-2:2018/Amd 1:2020.	Day 1 (up to one hour)

Collaborators and Investigators

• Sponsor: Welch Allyn

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2024
• Primary Completion (Actual): April 29, 2025
• Study Completion (Actual): April 29, 2025

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 60106449

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sharing of Clinical Trial Data: Baxter is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Baxter will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's)
• IPD Sharing Time Frame: Upon approval of a legitimate research request.
• IPD Sharing Access Criteria: Research requests will be reviewed by qualified medical and scientific experts within the company. If Baxter agrees to the release of clinical data for research purposes, the requestor will be required to sign a data sharing agreement (DSA) in order to ensure protection of patient confidentiality and any intellectual property rights of Baxter prior to the release of any data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes