跳至主要内容
临床试验/NCT06583252
NCT06583252招募中不适用

Effect of Multimodal Monitoring Cluster Management on Patients with Severe Traumatic Brain Injury

Xiangya Hospital of Central South University0 个研究点目标入组 200 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
主要终点
Glasgow Outcome Score-Extended at 6 months

研究概览

简要总结

Traumatic brain injury (TBI) is a serious global health problem, with about 27 million new cases each year. Severe head trauma can lead to intracranial hypertension and a range of complications such as cerebral edema and hypoxia of brain tissue. Intracranial pressure monitoring is key to modern TBI treatment, but this approach does not fully reflect all relevant pathophysiological changes. Multimodal monitoring allows for a more comprehensive assessment of the severity of TBI and guidance for individualized treatment to improve patient outcomes by integrating different monitoring methods. Although more research is needed to confirm its efficacy, multimodal monitoring has been recognized as an important clinical decision support tool in neuroscience intensive care. Future studies may further optimize this approach to monitoring and provide a more effective treatment strategy for patients with TBI.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1.Age >18 years, 2.Diagnosis of an acute brain injury (ABI) due to TBI, 3.GCS with Eyes response = 1 (no eyes opening) and Motor score ≤5 (not following commands) at the admission to intensive care unit (ICU) or neuro-worsen-ing within the first 48 hours with no eye opening and the Motor score decreased to ≤

排除标准

  • Have had a major stroke before.
  • Pregnant or likely to become pregnant. 3 In the opinion of the treatment team, the decrease in GCS (Glasgow Coma Scale) score is solely due to intoxication, sedation, or extracranial injury.
  • 4 Participants are unlikely to comply with all study procedures, including follow-up, in the opinion of the investigator.
  • Have an underlying medical condition with a life expectancy of less than 6 months.
  • There are pre-existing contraindications to MRI examination. 7 suffer devastating TBI, either progressing to brain death at the time of recruitment, or the treating medical team does not commit to continuous, comprehensive aggressive treatment.

结局指标

主要结局

Glasgow Outcome Score-Extended at 6 months

时间窗: 6 months

Glasgow Outcome Score-Extended at 6 months

次要结局

未报告次要终点

研究者

发起方
Xiangya Hospital of Central South University
申办方类型
Other
责任方
Sponsor

相似试验