Multimodal Monitoring of Cerebral Autoregulation After Pediatric Brain Injury (NCT04242602) | Clinical Trial Compass
CompletedNot Applicable
Multimodal Monitoring of Cerebral Autoregulation After Pediatric Brain Injury
United States29 participantsStarted 2018-11-06
Plain-language summary
Various methods have been studied to evaluate autoregulation. However, there is currently no universally accepted technique to assess integrity of the cerebral autoregulation neurovascular system. In the last decade, significant progress has been achieved in developing methods to assess cerebral autoregulation by quantifying cross-correlation between spontaneous oscillations in CBF or oxygenation and similar oscillations in arterial blood pressure.
In this study the investigators will analyze the relationship between spontaneous fluctuations in mean arterial blood pressure and cerebral blood flow velocity or cerebral regional oxygenation to investigate two novel methods for measuring cerebral autoregulation, Transfer Function Analysis and Wavelet Coherence after acute pediatric brain injury.
Who can participate
Age range
28 Days – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Ages 28 days-18 years admitted to the PICU at Children's Medical Center Dallas
* Acute presentation (\< 24 hour) onset of neurologic injury
* Acute neurologic injury can be due to any of the following mechanisms:
* Severe accidental or abusive traumatic brain injury
* Severe encephalopathy secondary to cardiac arrest
* Spontaneous intracranial hemorrhage
* Status epilepticus
* Stroke
* Presence of or pending placement of invasive indwelling arterial line for stand medical care
* Any patient with an ICP monitor placed as standard of care
Exclusion Criteria:
* Patients without an arterial line placed as standard of care
* Patients unable to cooperate with wearing a TCD headpiece device
* Expected death within 24-48 hours
* Inability to place NIRS probes or insonate TCD signal due to massive facial or cranial injury
* Receiving an inhalational anesthetic agent
* Hemoglobinopathy, myoglobinemia or and hyperbilirubinemia (due to inaccurate NIRS readings)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Transfer Function Analysis
Timeframe: Day 1 post injury
2
Transfer Function Analysis
Timeframe: Day 3 post injury
3
Transfer Function Analysis
Timeframe: Day 5 post injury
4
Transfer Function Analysis
Timeframe: Day 7 post injury
5
Transfer Function Analysis
Timeframe: Day 10 post injury
6
Wavelet Coherence Analysis
Timeframe: Day 10 post injury
7
Change in Glasgow Outcome Scale Extended-Pediatrics (GOSEP) score
Timeframe: 6 months post discharge.
8
Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) score
Trial details
NCT IDNCT04242602
SponsorUniversity of Texas Southwestern Medical Center