Testing a new blood pressure measurement device for infants and neonates

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

This study is testing a new device to see if it can accurately measure blood pressure in infants and newborns who already have a special line in their artery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: N/A to 3 Years
• Sex: All
• Sponsor: Baxter Healthcare Corporation (Industry-sponsored)
• Locations: 2 sites (Greenville, North Carolina and 1 other locations)
• Trial ID: NCT05976425 on ClinicalTrials.gov

What this trial studies

This study evaluates the accuracy of the ModPG3 device, which uses advanced algorithms to measure blood pressure in neonates and infants. The device employs the SureBP algorithm during cuff inflation and the StepBP algorithm during deflation to provide reliable readings. The goal is to determine if these algorithms meet the ISO 81060-2:2018/Amd 1:2020 standards for non-invasive sphygmomanometers. Participants will include infants under three years of age who already have an indwelling intra-arterial line.

Who should consider this trial

Good fit: Ideal candidates are neonates and infants under three years of age with an indwelling intra-arterial line.

Not a fit: Patients without an indwelling intra-arterial line or those with deformities preventing proper device application may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate blood pressure measurements in neonates and infants, improving clinical outcomes.

How similar studies have performed: Other studies have shown success with similar oscillometric devices, indicating a promising approach for accurate blood pressure measurement.

Eligibility criteria

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.

Where this trial is running

Greenville, North Carolina and 1 other locations

• East Carolina University — Greenville, North Carolina, United States (Recruiting)
• Azienda Ospedaliero - Universitaria Meyer — Firenze, Italy (Recruiting)

Study contacts

• Study coordinator: Baxter Clinical Trials Disclosure Call Center

Conditions Blood Pressure