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临床试验/CTRI/2024/11/077482
CTRI/2024/11/077482已完成不适用

Assessment of impaired cerebral autoregulation in patients with traumatic brain injury and its correlation with neurological outcomes: A prospective observational study

PGIMER, Chandigarh1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年12月9日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Effect of impaired cerebral autoregulation (ICA) on neurological outcome in patients with moderate to severe TBI via modified Rankin Scale

研究概览

简要总结

Cerebral autoregulation (CA) is an integral autoregulatory mechanism of our body by which blood flow to the brain is maintained in spite of fluctuations in blood pressure. Autoregulation can be assessed by observing changes in cerebral blood flow or its equivalents in response to differences in cerebral perfusion pressure or mean arterial pressure. TBI is one of the largest medical burdens worldwide. TBI survivors suffer from several post injury sequalae months or years after the event. Research indicates that post Traumatic Brain Injury (TBI) cerebral autoregulatory mechanisms are lost and this can result in secondary brain injury. TBI has been known to increase the incidence of several neurological dysfunctions like stroke, seizure disorder and incidence of all-cause mortality. There is a lacuna in available literature regarding the assessment of impaired cerebral autoregulation (ICA) in patients of TBI using TCD along with Transient Hyperaemic Response Test (THRT) and its correlation with neurological outcome. We hypothesize that impaired cerebral autoregulation during initial 48 hours following TBI can compromise cerebral perfusion which can lead to poorer neurological outcome.

Cerebral autoregulation monitoring in TBI is essential for guiding clinical decision-making and treatment protocols. On receiving patients in the Trauma and Neuro Intensive Care Unit, patients will be stabilised as per ICU protocol. Thereafter, patients will be screened for eligibility which includes bilateral carotid ultrasound to rule out carotid plaque or atheroma to avoid the disruption and dislodgement of the plaque during THRR test. Once the patients fulfil the eligibility criteria they will be enrolled for the study. Baseline demographics shall be recorded. TCD will be done at baseline, during Transient Hyperaemic Response Test and after THRT. Dynamic autoregulation will be assessed via THR. Mean flow velocity, peak flow velocity, diastolic flow velocity and pulsatality index (PI) will be noted.  THR test will be repeated at 48 hours. The outcomes, as mentioned above shall be assessed.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients with moderate to severe isolated Traumatic Brain Injury.

排除标准

  • Patients with mild head injury, carotid artery disease, history of ischemic stroke, inadequate TCD window, pregnancy, cervical spine fracture.

结局指标

主要结局

Effect of impaired cerebral autoregulation (ICA) on neurological outcome in patients with moderate to severe TBI via modified Rankin Scale

时间窗: 12 weeks

次要结局

  • Detect the incidence of impaired cerebral autoregulation (ICA) in TBI patients(At Admission to Neuro-Trauma ICU and at 48 hours)
  • Effect of ICA on duration of ICU stay(At discharge from ICU)
  • Correlation of ICA on neurological outcome with Modified Rankin Scale(At discharge from ICU)
  • Correlation of ICA on neurological outcome at discharge with Glassgow Coma Outcome Scale Extended(At 4 weeks)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sutapa Ray Chaudhuri

PGIMER, Chandigarh

研究点 (1)

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