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Brain Blood Flow and Cerebral Autoregulation Monitoring in Critically Ill Children

24. august 2026 opdateret af: University of Wisconsin, Madison

Transcranial Doppler Assessment of Cerebral Autoregulation and Blood Flow Velocity Patterns in Critically Ill Children: A Prospective Observational Study

This study uses a non-invasive (external) ultrasound test called Transcranial Doppler (TCD) to measure how blood flows through the major arteries of the brain of children receiving care in the Pediatric Intensive Care Unit (PICU). TCD is already used for clinical reasons in many children, but it is not part of routine monitoring for every critically ill child. By using TCD, the investigators hope to better understand how brain blood flow changes during illness. They will also track children's functional status from before their illness to the time of PICU discharge to explore how brain blood flow patterns relate to neurological outcomes.125 participants will be enrolled and will be on study while in the PICU, estimated to be 3-14 days.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Current clinical management of hemodynamics in critically ill children relies primarily on systemic parameters (e.g., blood pressure, heart rate) rather than direct assessment of cerebrovascular regulation. This approach may overlook individual variations in cerebral autoregulation (CA) capacity, potentially leading to suboptimal cerebral perfusion.

By prospectively evaluating TCD-derived CA indices in intubated pediatric patients with arterial blood pressure monitoring, this study aims to:

  1. Establish normative Cerebral blood flow velocity (CBFV) ranges for critically ill children
  2. Describe CBFV patterns across critically ill pediatric populations with varying neurologic risk profiles
  3. Characterize the prevalence of CA dysfunction in a heterogeneous PICU population
  4. Explore associations between CA/CBFV and functional outcomes

These data could:

  1. Provide age-stratified CBFV reference values for the PICU setting
  2. Identify patients at highest risk of neurological morbidity using population-specific thresholds
  3. Inform future trials of autoregulation-guided hemodynamic management

Undersøgelsestype

Observationel

Tilmelding (Anslået)

125

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Forenede Stater
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • Rekruttering
        • American Family Children's Hospital PICU
        • Underforsker:
          • Talal Al Hendawi, MD
        • Ledende efterforsker:
          • Neil Munjal, MD

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

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Mechanically ventilated pediatric patients (1 day-17.5 years) admitted to the PICU who meet eligibility criteria

Beskrivelse

Inclusion Criteria:

  • Has at least one Parent or Legal Guardian who is willing and able to provide informed consent in English
  • Mechanically ventilated (Endotracheal tube)
  • Indwelling arterial catheter
  • Current patient in the American Family Children's Hospital PICU.
  • 1 day to 17.5 years of age

Exclusion Criteria:

  • Subjects with a known or obvious anatomic barrier preventing safe application of the transcranial Doppler probe (e.g., cranial dressings, cranial fixation hardware, ventricular access devices positioned over insonation sites, or bilateral craniectomies)
  • Patient with known chronic hypertension
  • Admission FSS score > 16
  • Tracheostomized patient
  • The designated sub-investigator (Dr. Talal Al Hendawi) and PI (Dr. Neil Munjal) are unavailable to perform the Transcranial Doppler scan at the time of eligibility. All study scans are performed by either Dr. Al Hendawi or Dr.Munjal to ensure standardization and data integrity. Therefore, if they are unavailable (e.g., due to clinical service, leave, or other scheduling constraints), the patient will not be enrolled in the study.
  • Not suitable for study participation due to other reasons at the discretion of the investigators

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
PICU Patients
Mechanically ventilated pediatric patients (1 day-17.5 years) admitted to the PICU.
Enhed: Transcranial Doppler
TCD measurements synchronized to arterial blood pressure and ventilatory data, performed once daily for up to 5 days during PICU admission plus one additional pre-extubation scan if applicable, approximately 30 minutes each. Bilateral middle cerebral artery (MCA) insonation performed at each session.
Andre navne:
  • TCD

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Functional Status Scale (FSS) from baseline to PICU discharge
Tidsramme: Baseline FSS reflects pre-morbid functional status as reported by parents/guardians at enrollment; follow-up FSS assessed at PICU discharge (estimated 3-14 days)
To assess the relationship between cerebral autoregulation and neurological outcomes in critically ill pediatric patients, FSS will be measured. FSS has 6 domains: mental status, sensory, communication, motor function, feeding, and respiratory. FSS is scored from 6 to 30, higher scores are indicative of more severe dysfunction.
Baseline FSS reflects pre-morbid functional status as reported by parents/guardians at enrollment; follow-up FSS assessed at PICU discharge (estimated 3-14 days)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Flow Index (Mx)
Tidsramme: data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
Mean Flow Index (Mx) will serve as the primary exposure variable in multivariable regression analyses relating cerebral autoregulation status to functional outcome, and will additionally be characterized across PICU subpopulations.
data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
Percent successful exams (complete bilateral MCA data)
Tidsramme: data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
Feasibility metric reflecting the proportion of TCD sessions yielding complete bilateral MCA data, used to assess protocol feasibility and sonographic success rates in the PICU setting.
data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
Time per exam (min)
Tidsramme: data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
Feasibility metric reflecting total time required per TCD session, used to assess protocol efficiency and burden on clinical care.
data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
Mean CBFV
Tidsramme: data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
To describe cerebral blood flow velocity patterns in critically ill pediatric patients, mean CBFV will be measured.
data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
Age-stratified CBFV values across pre-specified clinical subgroups (TBI, cardiac arrest, ECMO)
Tidsramme: data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
Age-stratified Mx values across pre-specified clinical subgroups (TBI, cardiac arrest, ECMO)
Tidsramme: data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)

Samarbejdspartnere og efterforskere

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

Sponsor

University of Wisconsin, Madison

Efterforskere

  • Ledende efterforsker: Neil Munjal, MD, UW School of Medicine and Public Health

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)

3. august 2026

Primær færdiggørelse (Anslået)

1. maj 2028

Studieafslutning (Anslået)

1. maj 2028

Datoer for studieregistrering

Først indsendt

21. maj 2026

Først indsendt, der opfyldte QC-kriterier

21. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026-0238
  • SMPH/Pediatrics/Critical Care (Anden identifikator: UW Madison)
  • Protocol Version 3/3/26 (Anden identifikator: UW Madison)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

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