ModPG3 Neo-Infant ISO 81060

Study Overview
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Brief Summary
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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

Official Title
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ModPG3 Neonate and Infant AAMI (Association for the Advancement of Medical Instrumentation) 2018 ISO Clinical Investigation Protocol of SureBP and StepBP Algorithms

Conditions
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Blood Pressure

Intervention / Treatment
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* Device: ModPG3 Investigational Device
* Device: Invasive Reference Equipment


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood pressure readings<br>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<br>* Connex Vital Sign Monitor with ModPG3 Laptop Data Collection Software USB cable Power strip Welch Allyn FlexiPort Disposable Blood Pressure Cuffs<br>Device: Invasive Reference Equipment<br>* Surveyor S12/S19 Hill-Rom ICU Medical data collection cable DIR 60119852 Hill-Rom Edwards data collection cable DIR 60119853<br>|

What is the study measuring?
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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) |