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临床试验/CTRI/2025/02/081341
CTRI/2025/02/081341招募中不适用

To evaluate the effect of decompressive craniectomy on cerebral venous oxygen saturation (SjVO2) in traumatic brain injury patients

AIIMS, New Delhi1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年3月10日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
To compare jugular venous oximetry values before and after decompressive craniectomy (DC)

研究概览

简要总结

Traumatic brain injury (TBI) is one of the leading causes of morbidity and mortality worldwide.After the primary insult, secondary insult plays a major role in the pathophysiology of TBI. Factors leading to secondary insult include, hypotension, hypoxia, hypercarbia, decreased cerebral blood flow (CBF), decreased cerebral perfusion pressure (CPP), increased intracranial pressure (ICP), etc. Many protocols are followed by neuro-intensivists to minimize secondary insult and to maintain adequate CBF by decreasing ICP to <22 mm Hg and maintaining an optimum CPP between 60 to 70 mm Hg for adults (as per Brain Trauma Foundation (BTF) guidelines 2016).

Increased ICP is a common occurrence after TBI and decompressive craniectomy is required to reduce ICP and improve CPP if medical measures fail. However, CPP may not always improve despite a decrease in ICP in TBI patients and thus may lead to cerebral ischemia and infarction. The DECRA (Decompressive Craniectomy in Diffuse Traumatic Brain Injury) trial, in patients with severe TBI and refractory intracranial hypertension, showed that an early bifronto-temporo-parietal decompressive craniectomy led to a decrease in ICP and length of ICU stay but did not result into a better outcome. Cerebral ischemia and cerebral oxygenation are important factors for clinical outcome in TBI patients. Cerebral jugular venous oximetry (SjVO2) is a marker of global cerebral blood flow and brain metabolism that indicates the delivery and utilization of oxygen by brain cells. Along with SjVO2,cerebral arteriovenous oxygen difference (AVDO2), arterial-venous differences of glucose (AVDG), and venous-arterial difference of lactate (VADL) have also been used as surrogate markers of cerebral perfusion and metabolism.

Decompressive  craniectomy  has  an  established  role in decreasing ICP but has never been evaluated for its effect on jugular venous oximetry. Thus, there is no concrete evidence to state whether the decrease in ICP after decompressive craniectomy leads to improvement in cerebral blood flow and/or cerebral oxygenation which may result in improved clinical outcome. Considering these factors, this study is planned to determine whether decompressive craniectomy offers any advantage in terms of improved CBF and improved oxygen delivery to brain in moderate to severe TBI patients

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

  • 1.Age 18-65 yrs 2.Either sex 3.ASA Physical status I/II/III 4.Patient admitted within 48hrs of TBI 5.Moderate to severe TBI (GCS ≤ 12 after resuscitation) 6.Patients undergoing invasive ICP monitoring with a sustained rise in ICP refractory to medical management.

排除标准

  • 1.ASA physical status IV/ V 2.Any brain mass lesion requiring immediate 3.decompression 4.Patients with dilated unreactive pupils 5.Non-traumatic intracranial mass lesion 6.Past H/o any intracranial surgery 7.Coagulation abnormality 8.Unstable cervical spine injury 9.Pregnant and lactating patients.

结局指标

主要结局

To compare jugular venous oximetry values before and after decompressive craniectomy (DC)

时间窗: multiple readings will be taken at multiple timepoints starting before DC to 24 hours after DC.

次要结局

  • To correlate the lowest values of SjVO2 with the outcome (GOSE) at discharge and at 3 months

研究者

发起方
AIIMS, New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Karma Ongmu Bhutia

AIIMS New Delhi

研究点 (1)

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