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Non-Invasive Blood Pressure Monitor Accuracy in Neonatal Subjects

This study is currently recruiting participants.
Verified March 2016 by Mortara Instrument
Sponsor:
ClinicalTrials.gov Identifier:
NCT02642198
First Posted: December 30, 2015
Last Update Posted: March 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Mortara Instrument
  Purpose
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".

Condition Intervention Phase
Non-invasive Blood Pressure Device: Surveyor S12 and S19 patient monitor Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Clinical Investigation for Non-invasive Blood Pressure Monitor Accuracy Validation Performed on Neonatal, Infants and Children up to 3 Years Old

Further study details as provided by Mortara Instrument:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 25
Study Start Date: October 2015
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Surveyor S12 and S19 patient monitor
    Non-invasive blood pressure measurement
    Other Name: S12/S19
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642198


Contacts
Contact: Fiammetta Piersigilli, MD 06 - 6859 ext 2427 fiammetta.piersigilli@opbg.net
Contact: Zaccaria Ricci 06 - 6859 ext 2258 zaccaria.ricci@gmail.com

Locations
Italy
Ospedale Pediatrico Bambino Gesù (OPBG) Recruiting
Rome, Italy, 00165
Contact: Fiammetta Piersigilli, Doctor    06 - 6859 ext 2427    fiammetta.piersigilli@opbg.net   
Contact: Zaccaria Ricci, Doctor    06 - 6859 ext 2258    accaria.ricci@gmail.com   
Principal Investigator: Andrea Dotta, Doctor         
U.O. Neonatal Intensive Care Immature Pediatric Hospital Bambino Gesù - IRCCS Recruiting
Rome, Italy, 00165
Contact: Fiammetta Piersigilli, Doctor    06 - 6859 ext 2427    fiammetta.piersigilli@opbg.net   
Contact: Zaccaria Ricci, Doctor    06 - 6859 ext 2258    zaccaria.ricci@gmail.com   
Principal Investigator: Andrea Dotta, MD         
Sub-Investigator: Corrado Cechetti, MD         
Sponsors and Collaborators
Mortara Instrument
  More Information

Responsible Party: Mortara Instrument
ClinicalTrials.gov Identifier: NCT02642198     History of Changes
Other Study ID Numbers: 900_OPBG_2015
First Submitted: December 22, 2015
First Posted: December 30, 2015
Last Update Posted: March 23, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mortara Instrument:
NiBP