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A Bedside, Single Burr Hole Approach to Multimodality Monitoring in Severe Brain Injury
Published on: March 26, 2019
Development of a Randomized Trial Comparing ICP-Monitor-Based Management of Severe Pediatric Traumatic Brain Injury
Randall Chesnut1,2,3,4, Nancy Temkin1,5, James Pridgeon1
1Department of Neurological Surgery, University of Washington, Seattle , Washington , USA.
Insights
This study compares intensive care unit management protocols for severe traumatic brain injury (TBI) in children, evaluating if intracranial pressure (ICP) monitoring improves outcomes. Findings will guide TBI treatment standards.
Area of Science:
- Pediatric critical care medicine
- Neurotrauma research
- Clinical trial methodology
Background:
- Traumatic brain injury (TBI) is a significant cause of death and disability in children globally.
- Increased intracranial pressure (ICP) is common in pediatric TBI, but its management efficacy is debated.
- Current management strategies for severe pediatric TBI lack definitive evidence regarding ICP monitoring's benefit.
Purpose of the Study:
- To provide Class I evidence on the efficacy of an intracranial pressure (ICP) monitoring-based management protocol versus non-ICP monitoring care in pediatric severe TBI.
- To determine the impact of protocolized ICP management on 6-month outcomes in children with severe TBI.
- To inform clinical practice guidelines for managing severe pediatric TBI.
Main Methods:
- A phase III, multicenter, randomized superiority trial involving children aged 1-12 years with severe TBI (Glasgow Coma Scale score ≤8).
- Patients were randomized to either ICP-based management or management based on imaging and clinical examination without ICP monitoring.
- The trial was conducted in intensive care units across Central and South America.
Main Results:
- Primary outcome: 6-month Pediatric Quality of Life.
- Secondary outcomes: 3-month Pediatric Quality of Life, mortality, 3- and 6-month Pediatric extended Glasgow Outcome Score, ICU length of stay, and interventions for intracranial hypertension.
- The study aims to determine if ICP-based management offers superior outcomes compared to standard care.
Conclusions:
- This research will clarify the added value of protocolized ICP management in severe pediatric TBI.
- Demonstrating efficacy could lead to standardized ICP monitoring protocols in pediatric neurotrauma.
- Alternative findings may necessitate a reevaluation of ICP data application in TBI care.
Background And Objectives:
Traumatic brain injury (TBI) is a major global public health problem. It is a leading cause of death and disability in children and adolescents worldwide. Although increased intracranial pressure (ICP) is common and associated with death and poor outcome after pediatric TBI, the efficacy of current ICP-based management remains controversial. We intend to provide Class I evidence testing the efficacy of a protocol based on current ICP monitor-based management vs care based on imaging and clinical examination without ICP monitoring in pediatric severe TBI.
Methods:
A phase III, multicenter, parallel-group, randomized superiority trial performed in intensive care units in Central and South America to determine the impact on 6-month outcome of children aged 1-12 years with severe TBI (age-appropriate Glasgow Coma Scale score ≤8) randomized to ICP-based or non-ICP-based management.
Expected Outcomes:
Primary outcome is 6-month Pediatric Quality of Life. Secondary outcomes are 3-month Pediatric Quality of Life, mortality, 3-month and 6-month Pediatric extended Glasgow Outcome Score, intensive care unit length of stay, and number of interventions focused on treating measured or suspected intracranial hypertension.
Discussion:
This is not a study of the value of knowing the ICP in sTBI. This research question is protocol-based. We are investigating the added value of protocolized ICP management to treatment based on imaging and clinical examination in the global population of severe pediatric TBI. Demonstrating efficacy should standardize ICP monitoring in severe pediatric TBI. Alternate results should prompt reassessment of how and in which patients ICP data should be applied in neurotrauma care.
