Blood Pressure, Blood Pressure Measurement
Conditions
Brief summary
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
DEVICENIBP 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.
Sponsors
GE Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measure | Up to 12 hours from time of study procedure start | Collection of non-invasive blood pressure measurements data from subjects in clinical setting. |
Countries
Finland
Contacts
CONTACTOtto Rahkonen Principal Invastigator
Outcome results
None listed