Non-Invasive Blood Pressure Monitor Accuracy in Neonatal Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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".

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Measurement of Arterial Blood Pressure by L&T NIBP Module With Invasive Arterial Blood Pressure in Neonates

NCT01196806

Blood Pressure

COMPLETED

Office, Home, and Ambulatory Blood Pressure

NCT05297708

Elevated Blood Pressure

ACTIVE_NOT_RECRUITING

Evaluation of Continuous Non Invasive Blood Pressure With Adult Volunteers

NCT04876664

Blood Pressure

UNKNOWN NA

Comparison of Non-Invasive Blood Pressure Methods

NCT04296227

Blood Pressure

COMPLETED NA

Somnotouch-NIBP Compared to Standard Ambulatory 24 Hours Blood Pressure Measurement

NCT03054688

Blood Pressure

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-invasive Blood Pressure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Surveyor S12 and S19 patient monitor

Non-invasive blood pressure measurement

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

S12/S19

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.

Minimum Eligible Age

29 Days

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes