Non-invasive Blood Pressure
Conditions
Keywords
NiBP
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.
Interventions
DEVICESurveyor S12 and S19 patient monitor
Non-invasive blood pressure measurement
Sponsors
Mortara Instrument
Study design
Observational model
CASE_ONLY
Eligibility
Sex/Gender
ALL
Age
29 Days to 3 Years
Healthy volunteers
Yes
Inclusion criteria
Patient inclusion criteria Before proceeding with the blood pressure non-invasive measurements detection, patients shall be examined and met the following stated criteria: * Patients shall have already an invasive blood pressure monitoring (with catheter), this criteria applies only for Method 1. * It shall be possible to perform multiple measurements of Non Invasive Blood pressure on one or more limbs with inflatable cuff. * Patient with weight and age range according to the protocol requirements previously defined. * Once the patient is identify a pre-screening activities is performed in order to assess any differences in the blood pressure. If the differences are minimal, according to the criteria described in the next section
Exclusion criteria
, the patient can be included in the study group.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Contacts
Primary ContactFiammetta Piersigilli, MD
Backup ContactZaccaria Ricci
Outcome results
None listed