Brain Blood Flow and Cerebral Autoregulation Monitoring in Critically Ill Children

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-17
SponsorUniversity of Wisconsin, Madison

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

125 Participants
are divided into 1 treatment group
Group A: PICU Patients1 intervention

Trial outcomes

Primary outcomes

1

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

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.

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)

Secondary outcomes

1

Mean Flow Index (Mx)

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.

Time frame
data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
2

Percent successful exams (complete bilateral MCA data)

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.

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

Time per exam (min)

Feasibility metric reflecting total time required per TCD session, used to assess protocol efficiency and burden on clinical care.

Time frame
data collected while in PICU, from consent (baseline) to discharge (estimated 3-14 days)
4

Mean CBFV

To describe cerebral blood flow velocity patterns in critically ill pediatric patients, mean CBFV will be measured.

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

Other outcomes

Sponsors and contacts

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