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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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