Non-Invasive Blood Pressure Monitor Accuracy in Neonatal Subjects
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ClinicalTrials.gov Identifier: NCT02642198
Recruitment Status : Unknown
Verified March 2016 by Mortara Instrument. Recruitment status was: Recruiting
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 or disease
Non-invasive Blood Pressure
Device: Surveyor S12 and S19 patient monitor
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.
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
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Ages Eligible for Study:
up to 3 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.
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;