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Brain Blood Flow and Cerebral Autoregulation Monitoring in Critically Ill Children

24. august 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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

Studietype

Observasjonsmessig

Registrering (Antatt)

125

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53792
        • Rekruttering
        • American Family Children's Hospital PICU
        • Underetterforsker:
          • Talal Al Hendawi, MD
        • Hovedetterforsker:
          • Neil Munjal, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
PICU Patients
Mechanically ventilated pediatric patients (1 day-17.5 years) admitted to the PICU.
Enhet: 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 navn:
  • TCD

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Wisconsin, Madison

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. august 2026

Primær fullføring (Antatt)

1. mai 2028

Studiet fullført (Antatt)

1. mai 2028

Datoer for studieregistrering

Først innsendt

21. mai 2026

Først innsendt som oppfylte QC-kriteriene

21. mai 2026

Først lagt ut (Faktiske)

29. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

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