Recruiting

Transcranial Doppler

Sponsor:

University of Wisconsin, Madison

Code:

NCT07613918

Conditions

Critical Illness

Pediatric Critical Illness

Respiratory Failure

Traumatic Brain Injury

Cardiac Arrest

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Transcranial Doppler

Study Details

Brief summary:

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.

Conditions

Critical Illness

Pediatric Critical Illness

Respiratory Failure

Traumatic Brain Injury

Cardiac Arrest

Study ID

NCT07613918

Start date

Aug 3, 2026

Status verified date

Aug, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

125 participants

Anticipated

Interventions and Outcome Measures

Arms

PICU Patients

Mechanically ventilated pediatric patients (1 day-17.5 years) admitted to the PICU.

Interventions

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.

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Meg Baker

meg.baker@wisc.edumeg.baker@wisc.edu

Locations

American Family Children's Hospital PICU

Recruiting

Madison, Wisconsin, United States, 53792

Principal Investigator:

Neil Munjal, MD

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • PICU
  • infant
  • Transcranial Doppler Assessment
  • Cerebral Autoregulation
  • Blood Flow Velocity
  • children
  • mechanical ventilation
  • neurocritical care
  • pulsatility index
  • Mean flow index
  • neonate
  • pediatric critical care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-08-27.