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

SunTech Medical

Status

Withdrawn

Conditions

Hypertension

Treatments

Device: Advantage MX Module

Study type

Observational

Funder types

Other

NETWORK

Identifiers

NCT06172829

Advantage MX Neonate-Infant

Details and patient eligibility

About

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.

Sex

All

Ages

1 month to 3 years old

Volunteers

Accepts Healthy Volunteers

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