Brain Blood Flow and Cerebral Autoregulation Monitoring in Critically Ill Children

June 2, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • American Family Children's Hospital PICU
        • Sub-Investigator:
          • Talal Al Hendawi, MD
        • Principal Investigator:
          • Neil Munjal, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PICU Patients
Mechanically ventilated pediatric patients (1 day-17.5 years) admitted to the PICU.
Device: 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.
Other Names:
  • TCD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
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.
data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
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.
data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
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.
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)
Time Frame: 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)
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

May 21, 2026

First Submitted That Met QC Criteria

May 21, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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