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NCT Number: NCT07613918

Brain Blood Flow and Cerebral Autoregulation Monitoring in Critically Ill Children

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.

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Key information

Conditions

Critical Illness Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiac Arrest Cardiovascular Diseases Central Nervous System Diseases Craniocerebral Trauma Disease Attributes Heart Arrest Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric Critical Illness Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Trauma, Nervous System Traumatic Brain Injury Wounds and Injuries

Age range

1 day–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

American Family Children's Hospital PICU

Madison, Wisconsin, 53792, United States

Location contact

Neil Munjal, MD

PRINCIPAL_INVESTIGATOR

Talal Al Hendawi, MD

SUB_INVESTIGATOR

About this study

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:

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

These data could:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Doppler

Device

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.

Other names: TCD

Primary outcomes

  1. Change in Functional Status Scale (FSS) from baseline to PICU discharge

    Time frame: 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.

Secondary outcomes

  1. Mean Flow Index (Mx)

    Time frame: 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.

  2. Percent successful exams (complete bilateral MCA data)

    Time frame: 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.

  3. Time per exam (min)

    Time frame: 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.

  4. Mean CBFV

    Time frame: 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.

  5. Age-stratified CBFV values across pre-specified clinical subgroups (TBI, cardiac arrest, ECMO)

    Time frame: data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)

  6. Age-stratified Mx values across pre-specified clinical subgroups (TBI, cardiac arrest, ECMO)

    Time frame: data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)

Study contacts

Contact information is provided by the study sponsor or research team.

Meg Baker

CONTACT

[email protected]

[email protected]

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 29, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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