Pediatric cerebral performance category score based prediction of outcome in pediatric traumatic brain injury patients comparing transcranial doppler versus conventional management in neurocritical care a randomised control trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To assess the short-term neurological outcome in paediatric head injury patients at discharge and at 3 months on the basis of score called Paediatric Cerebral Performance Category (PCPC) score.
研究概览
简要总结
Paediatric head injury is a significant concern globally. A variety of advanced diagnostic and monitoring devices to manage acute traumatic brain injury (TBI) effectively. These tools are crucial for detecting both primary and secondary brain injuries and guiding therapy for optimal management. TCD is commonly used non-invasive technique for ICP measurement in ICU and Operation theatres. TCD allows evaluation of ICP by measuring Pulsatility index (PI) values of the middle cerebral and other cerebral vessels, cerebral blood flow mean velocities. PI values greater than 1.2 represent high resistance blood flow and has been most associated with increased ICP. For an assessment of general function status in large scale paediatric studies the Paediatric Cerebral Performance Category (PCPC) score is more reliable and suitable.
Hence, we plan to conduct a randomised control trial to assess the neurological outcome in paediatric head injury patients in TCD based management group versus conventional management group using PCPC score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Consent given by parents or guardian Moderate traumatic brain injury (Glassgow coma scale 9-12) Severe traumatic brain injury (Glassgow coma scale less than 8).
排除标准
- •Previous history of traumatic brain injury Visual disorder that precluded neurocognitive testing Presence of a neurological condition other than traumatic brain injury confirmed or reported by parents Mild traumatic brain injury Patients expired within 3 months of ICU discharge.
结局指标
主要结局
To assess the short-term neurological outcome in paediatric head injury patients at discharge and at 3 months on the basis of score called Paediatric Cerebral Performance Category (PCPC) score.
时间窗: At discharge and at 3 months after discharge.
次要结局
- 1. Initial Rotterdam Computed tomography score for prediction of outcome.(2. FOUR score based assessment and prediction of outcome of all paediatric head injury patients.)
研究者
Asmita Gupta
Postgraduate Institute of Medical Education and Research, Chandigarh