Non-Invasive Blood Pressure Monitor Accuracy in Neonatal Subjects

Non-invasive Blood Pressure Clinical Trial

Official title:

Clinical Investigation for Non-invasive Blood Pressure Monitor Accuracy Validation Performed on Neonatal, Infants and Children up to 3 Years Old

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02642198
• Other study ID #: 900_OPBG_2015
• Status: Recruiting
• Phase: Phase 1
• First received: December 22, 2015
• Last updated: March 22, 2016
• Start date: October 2015

Study information

• Verified date: March 2016
• Source: Mortara Instrument
• Contact: Fiammetta Piersigilli, MD
• Phone: 06 - 6859
• Email: fiammetta.piersigilli[@]opbg.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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".

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Years

Eligibility

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.

Exclusion criteria

• Patients with unstable clinical or cardiovascular conditions;

• Patients with circulatory problems which can results in different blood pressure values in the limbs;

• patients with heart disease which can results in blood pressure wave morphology abnormalities;

• patients where the difference of systolic blood pressure between two limbs is greater than 15 mm Hg or the difference of lateral diastolic blood pressure is greater than 10mmHg;

• Patients with arrhythmias.

Related Conditions & MeSH terms

• Non-invasive Blood Pressure

Intervention

Device:
• Surveyor S12 and S19 patient monitor
Non-invasive blood pressure measurement

Locations

Country	Name	City	State
Italy	Ospedale Pediatrico Bambino Gesù (OPBG)	Rome
Italy	U.O. Neonatal Intensive Care Immature Pediatric Hospital Bambino Gesù - IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Mortara Instrument

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	To study the accuracy of non-invasive blood pressure measurements in neonatal patients	4 hours per patient