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临床试验/NCT05688462
NCT05688462已完成不适用

Studying Trends of Auto-Regulation in Severe Head Injury in Paediatrics

Shruti Agrawal1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2018年7月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Shruti Agrawal

Consultant PIC

Cambridge University Hospitals NHS Foundation Trust

研究点 (1)

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