Clinical Validation of Suntech Advantage MX With Suntech Neonate and Children Cuff Line

Study Overview
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Brief Summary
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Patients will be selected according to specific criteria. Upon selection, patients with an existing intra-arterial line will have their blood pressure monitored with the SunTech Advantage MX module in addition to the reference data collected from intra-arterial line. Data collected from the Advantage MX module will be compared to the reference data from the intra-arterial line.

Official Title
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Clinical Validation of Suntech Advantage MX With Suntech Neonate and Children Cuff Line Against Invasive Intra-arterial Reference According to the ANSI/AAMI/ISO 810602-2019 Protocol for Neonates, Infants, Children

Conditions
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Hypertension

Intervention / Treatment
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* Device: Advantage MX Module


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 3 subjects shall be < 1,000g in weight. At least 3 subjects shall be 1,000g to 2,000g in weight. At least 3 subjects shall be >2,000g At least 3 subjects shall be ≥ 29 days and < 1 year of age. At least 3 subjects shall be ≥ 1 year and < 3 years of age. Exclusion Criteria: Subjects who study personnel determine invasive blood pressure measurements will be unreliable Patients found to have a-fib, irregular heart rhythm, dysrhythmias, bigeminy, trigeminy, and isolated premature ventricular beats (VPBs) during the enrollment process are to be ineligibile to participate in the study Patients who are prescribed anti-coagulation medication during the enrollment process or begin anti-coagulation medication after enrollment are ineligible to participate in the study. Exclusions can also occur post-data review based on exclusion criteria according to ANSI/AAMI/ISO 81060-2:2019

Ages Eligible for Study
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Minimum Age: 1 Month
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| At least 3 subjects shall be <1,000g in weight<br> | Device: Advantage MX Module<br>* no intervention will be provided.<br>|
| At least 3 subjects shall be 1,000g to 2,000g in weight<br> | Device: Advantage MX Module<br>* no intervention will be provided.<br>|
| At least 3 subjects shall be >2,000g<br> | Device: Advantage MX Module<br>* no intervention will be provided.<br>|
| At least 3 subjects shall be >/= 29 days and < 1 year of age<br> | Device: Advantage MX Module<br>* no intervention will be provided.<br>|
| At least 3 subjects shall be >/= 1 year and <3 years of age<br> | Device: Advantage MX Module<br>* no intervention will be provided.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The blood pressure measurement | collected from the Advantage MX module matches the intra-arterial line data | approximately 1 hour |