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NIBP Study for Neonate and Pediatric Subject Populations

29. juni 2026 opdateret af: GE Healthcare

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

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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

110

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Finland
      • Helsinki, Finland, 00290
        • Rekruttering
        • Helsinki University Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Child Cuff vs Small Adult Cuff (Upper arm overlap, 17-19 cm)
Subjects with an upper-arm circumference within 17-19 cm, where both Child Cuff and small adult cuffs are suitable, are randomized in a 1:1 ratio to receive blood pressure measurements using either: Child Cuff or Small Adult cuff Subjects with upper-arm circumferences in non-overlapping small adult -only ranges are assigned the Small Adult cuff without randomization and are not included in this arm.
Enhed: 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.
Aktiv komparator: Small Adult vs Adult Cuff (Upper arm overlap, 23-25cm)
Subjects with an upper-arm circumference within 23-25 cm, where both Small Adult (SA) and Adult (A) cuffs are suitable, are randomized in a 1:1 ratio to receive blood pressure measurements using either: -Small Adult cuff, or -Adult cuff Subjects with upper-arm circumferences in non-overlapping SA-only ranges are assigned the Small Adult cuff without randomization and are not included in this arm.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Primary Outcome Measure
Tidsramme: Up to 12 hours from time of study procedure start
Collection of non-invasive blood pressure measurements data from subjects in clinical setting.
Up to 12 hours from time of study procedure start

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety Outcome
Tidsramme: 6 months
Analysis of adverse events will be listed per subject, summarized with counts and percentages of events, and summarized with counts and percentages of subjects with events.
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

GE Healthcare

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. maj 2025

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

31. marts 2025

Først indsendt, der opfyldte QC-kriterier

29. juni 2026

Først opslået (Faktiske)

6. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • SA-000054

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Blodtryksmåling

Kliniske forsøg med NIBP Measurement

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Paraguay

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner