Non-Invasive Blood Pressure Monitor Accuracy in Neonatal Subjects

March 22, 2016 updated by: Mortara Instrument

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

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".

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00165
        • Recruiting
        • Ospedale Pediatrico Bambino Gesu (OPBG)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrea Dotta, Doctor
      • Rome, Italy, 00165
        • Recruiting
        • U.O. Neonatal Intensive Care Immature Pediatric Hospital Bambino Gesù - IRCCS
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrea Dotta, MD
        • Sub-Investigator:
          • Corrado Cechetti, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 3 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will include a minimum of 25 patients for the Method 1 and 20 patient for the Method 2, male and female, with the following weight and age (as defined by date of birth to current date; not gestational age) ranges:

  • At least 3 patients < 1,000 g in weight.
  • At least 3 patients 1,000 g to 2,000 g in weight.
  • At least 3 patients > 2,000 g in weight.
  • At least 3 patients ≥ to 29 days and < 1 year of age.
  • At least 3 patients ≥ 1 year and < 3 years of age.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 4 hours per patient
To study the accuracy of non-invasive blood pressure measurements in neonatal patients
4 hours per patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mortara Instrument

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

December 22, 2015

First Submitted That Met QC Criteria

December 23, 2015

First Posted (Estimate)

December 30, 2015

Study Record Updates

Last Update Posted (Estimate)

March 23, 2016

Last Update Submitted That Met QC Criteria

March 22, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 900_OPBG_2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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