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

SunTech Medical

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Hypertension

Interventions

Advantage MX ModuleDEVICE

no intervention will be provided.

Eligibility

Sex: ALLMin age: 1 MonthMax age: 3 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital of Los Angeles

Los Angeles, California, United States

Outcomes

Primary Outcomes

The blood pressure measurement

collected from the Advantage MX module matches the intra-arterial line data

Time frame: approximately 1 hour

Data from ClinicalTrials.gov

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