Studying Trends of Auto-Regulation in Severe Head Injury in Paediatrics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- To detect thresholds of PRx associated with favourable outcome in PTBI
研究概览
简要总结
Children are known to have devastating impact from traumatic brain injury (TBI). The focus of treatment of severe TBI is to limit secondary insult which can aggravate brain injury and worsen outcome and is supported by monitoring brain pressure (ICP) and arterial pressure (ABP). These pressures, if incorporated in Multi-modality monitoring can be used to interpret state of mechanisms used by brain to maintain normal blood flow. This has been advised to guide management of severe TBI in adults, however, there is limited experience with advanced brain monitoring in children. The investigators propose to study the use of this in children with severe TBI. Children (up to 16 years of age) with a severe TBI are referred to a neurosurgical unit (NSU) and admitted to a paediatric intensive care unit (PICU) as part of usual NHS clinical practice. All patients with a severe TBI require a monitoring wire to be inserted into the brain to read the pressure inside the skull and a similar device in an artery to monitor the blood pressure. These recordings are documented by a PICU nurse at a prescribed frequency. Without interrupting this clinical practice investigators propose to record these values using computer software called ICM+. These recordings will provide real time analysis and a continual recording of important parameters which will provide the study with much needed information on the patterns of pressures in the brain after this injury in children. All patients will be followed up for 12 months to see how well they recover, neuropsychology assessment will be performed by a Neuropsychologist at the recruiting centre using a standardised form.
详细描述
This is an observational prospective cohort study. Children admitted to ten identified PICUs in the UK with severe TBI with a clinical need for ICP and ABP monitoring are being included for data collection. The database will contain routinely monitored physiological parameters during management of PTBI in PICU. Without disturbing the routine care and management of these patients, investigators are collecting this data continuously in a bedside laptop equipped with the study software (ICM+, Cambridge Enterprise Ltd, Cambridge, UK). Alongside these physiological parameters, investigators are also collecting relevant clinical and demographic data (details below) and follow these patients for up to 12 months post ictus to assess neuro-psychological outcome. The created database will be used to analyze the state of cerebral autoregulation. Investigators will also analyze the data to see if investigators can derive optimal cerebral perfusion pressures based on the state of autoregulation and compare it with the patient outcome at 6 and 12 months. The database can also be subsequently used in the future projects testing hypotheses inspired by the experience gained in the adult TBI population research & to answer important questions about severe PTBI.
Inclusion Criteria:
- Patients 16 years old or younger at the time of injury
- Admitted to PICU for management of TBI
- TBI-related pathology confirmed on CT or MRI
- Clinical requirement for invasive monitoring of ICP and ABP
Exclusion Criteria:
- None
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Months 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 16 years old or younger at the time of injury
- •Admitted to PICU for management of TBI
- •TBI-related pathology confirmed on CT or MRI
- •Clinical requirement for invasive monitoring of ICP and ABP
排除标准
- 未提供
结局指标
主要结局
To detect thresholds of PRx associated with favourable outcome in PTBI
时间窗: 12 months
次要结局
- Establish a comprehensive paediatric database of a basic set of high resolution (pulse waveforms resolution) neuro-monitoring data including ICP, ABP and ECG(12 months)
- Characterise patterns of optimal CPP in PTBI as a function of age, severity and character of injury, intracranial pressure(12 months)
- Compare the fluctuations in these measured parameters with the outcome.(12 months)
研究者
Shruti Agrawal
Consultant PIC
Cambridge University Hospitals NHS Foundation Trust
