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Recruiting NCT07684885

NIBP Study for Neonate and Pediatric Subject Populations

No phase Interventional Blood Pressure Blood Pressure Measurement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NIBP Measurement.
Who it may be relevant to
Registry conditions: Blood Pressure, Blood Pressure Measurement. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Non-Invasive Blood Pressure Accuracy Study for Neonate and Pediatric Subject Populations

Overview

The purpose of this study is developing new NIBP enhancement and test it in clinical environment with neonates and children population subjects.

Detailed description

The purpose of the study is to collect clinical data for validation of the accuracy of non-invasive blood pressure (NIBP) measurement algorithms on the Non-invasive Blood Pressure (NIBP) Standard Parameter Module (SPM) per IEC 80601-2-30:2018, Medical electrical equipment-Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers standard, section 201.106. In addition, the study will be conducted per ISO 81060-2:2018+AMD2:2024 Non-invasive sphygmomanometers-Part 2: Clinical investigation of intermittent automated measurement type.

Interventions

  • Device NIBP Measurement
    The collection of non-invasive blood pressure measurements using NIBP Standard Parameter Module with SuperSTAT algorithm with simultaneous invasive blood pressure waveform recordings per discretion of the sponsor upon combining the data from other clinical studies to comply with ISO 81060-2:2018 +AMD2:2024.

Primary outcome measures

  • Primary Outcome Measure [Time frame: Up to 12 hours from time of study procedure start]

Eligibility criteria

Inclusion criteria

  • Age requirement: 0 to < 18 years.
  • For children under 15 years old: Has a guardian or other legal representative who is able to provide consent of a guardian OR
  • For children between the age of 15-17 years; able to provide written consent form and the legal guardians can be reached to be informed of the study participation.
  • Have an upper limb (right OR left side) that fits the cuff size of the device (circumference ranging 3 cm to 33 cm) OR have a thigh (right OR left side) that fits a cuff size of the device (circumference ranging 38 to 50 cm).
  • Have an arterial line as a standard of care, which measures invasive blood pressure.
  • Expected to remain in the unit for the duration of the study procedure.

Exclusion criteria

  • Have previously participated in this study (no subject may participate more than once).
  • Subjects with peripheral arterial diseases (causing left/right arm difference).
  • Hemodynamically unstable subjects Subjects with complications on vasoactive agents at discretion of the Investigator.
  • Exhibited injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the Investigator, may prevent proper cuff application or functioning.
  • Are suffering from infection(s) or immunocompromised subjects that require isolation.
  • For adolescents of child-bearing potential, who are currently pregnant, suspected to be pregnant, or are currently lactating.
  • PI, designee or caring physician decision due to subject health conditions

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Finland · 2 centers
  • Helsinki University Hospital — Helsinki
  • Helsinki University Hospital — Helsinki

Identifiers

NCT: NCT07684885 · SA-000054

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗