Monitoring brain blood flow regulation in children after injury
Multimodal Monitoring of Cerebral Autoregulation After Pediatric Brain Injury
NA · University of Texas Southwestern Medical Center · NCT04242602
This study is testing new ways to monitor how children's brains control blood flow after they've had a brain injury to help improve their care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 28 Days to 18 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center (other) |
| Drugs / interventions | cart |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT04242602 on ClinicalTrials.gov |
What this trial studies
This study investigates two novel methods for assessing cerebral autoregulation in pediatric patients who have experienced acute brain injuries. By analyzing the relationship between fluctuations in mean arterial blood pressure and cerebral blood flow velocity or oxygenation, researchers aim to improve understanding of how the brain regulates blood flow after injury. The study utilizes Transcranial Doppler technology to gather data from children admitted to the pediatric intensive care unit with various types of acute neurologic injuries. The goal is to establish effective monitoring techniques that could enhance patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include children aged 28 days to 18 years who have suffered acute neurologic injuries and are admitted to the pediatric intensive care unit.
Not a fit: Patients who are expected to die within 24-48 hours or those unable to cooperate with the monitoring devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of cerebral autoregulation in pediatric patients, potentially reducing long-term neurological disabilities.
How similar studies have performed: While various methods for assessing cerebral autoregulation have been explored, this specific approach using Transcranial Doppler and novel analysis techniques is relatively novel and has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Dallas, Texas
- Children's Medical Center — Dallas, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Darryl Miles — University of Texas Southwestern Medical Center
- Study coordinator: Danyal Thaver
- Email: danyal.thaver@utsouthwestern.edu
- Phone: 2144567592
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Traumatic Brain Injury, Brain Injuries, Brain Injury, Vascular