Non-Invasive Blood Pressure Monitor Accuracy in Neonatal Subjects

• Conditions: Non-invasive Blood Pressure

• Registration Number: NCT02642198
• Lead Sponsor: Mortara Instrument

Brief Summary

This study is being conducted to validate the accuracy of non-invasive blood pressure (NIBP) measurement technology from Mortara Instrument, Inc. (Milwaukee, Wisconsin, USA) and Zoe Medical, Inc. (Topsfield, Massachusetts, USA) in a neonatal, infants and children up to 3 years old patient population. The study is defined according to the International Standard "ANSI/AAMI/ISO 81060-2:2013, Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type".

Detailed Description

The device under test is Mortara Instrument's Surveyor S12/S19 patient monitors ("Surveyor") incorporating neonatal NIBP technology. Specifically, NIBP measurements will be taken using a cuff on the patient's limb (exact location will be determined by clinician) using a variety of cuffs sized for neonates and pediatrics. The device utilizes oscillometric technology to obtain quickly and conveniently non-invasive blood pressure measurements. Results will be compared to invasive blood pressure measurements from patients already monitored with such sensors. The Device under Test will be calibrated and verified by a Mortara representative on site.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-12-22
• Study First Submitted QC: 2015-12-23
• Study First Posted: 2015-12-30
• Status Verified: 2016-03
• Primary Completion: 2016-03
• Last Update Submitted: 2016-03-22
• Last Update Posted: 2016-03-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study is the non-invasive blood pressure measurements accuracy validation performed with the Surveyor S12 / S19 monitor in pediatric, infants and children up to 3 years patients per ISO 81060-2: 2013 requirements.	4 hours per patient	To study the accuracy of non-invasive blood pressure measurements in neonatal patients

Trial Locations

Locations (2)

Ospedale Pediatrico Bambino Gesù (OPBG); 🇮🇹 Rome, Italy

U.O. Neonatal Intensive Care Immature Pediatric Hospital Bambino Gesù - IRCCS; 🇮🇹 Rome, Italy