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临床试验/NCT05346471
NCT05346471招募中不适用

Infra- and Supratentorial Neuromonitoring in Patients With Posterior Fossa Lesions: DUAL-ICP Trial

Medical University Innsbruck2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年6月3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
30
试验地点
2
主要终点
Incidence of device-related events [Safety and Tolerability]

研究概览

简要总结

Invasive neuromonitoring of intracranial pressure (ICP) is an important element of neurosurgical critical care that is used primarily as an indicator of adequate cerebral perfusion in patients, when clinical observation is not an option. Due to the constraint in size and the critical structures within the posterior fossa, detection of intracranial pressure particularly in the postoperative phase has been deemed desirable in patients with surgery in this region, particularly in those subjected to prolonged procedures and critical care.

The posterior fossa is an anatomically constricted compartment with narrow spaces and intracranial hypertension quickly leads to brainstem damage and neurological dysfunction. ICP in the supratentorial space not necessarily correlates with ICP in the infratentorial space. Some authors claim that it would be beneficial to measure ICP in infratentorial space after posterior fossa surgery in some cases.

The relationship between the intracranial pressure profiles in the supratentorial and infratentorial compartments remain unclear. After a neurosurgical operation in the posterior fossa there are most likely pressure differences between supra- and infratentorial spaces. It is well known that the pressure within the skull is unevenly distributed, with appreciable ICP gradients.

Thus, the investigators intend to apply the intracranial multimodal monitoring in both infratentorial and supratentorial compartments simultaneously. Such coincident measurements most likely will be the most sensitive way to assess focal swelling, ischemia and tissue perfusion, or other relevant complications in the posterior fossa structures.

The goal of this study is to test whether direct infratentorial monitoring is a more efficacious method for detecting dynamic changes in the operative compartment and whether it is safe, in view of the critical structures within the region.

详细描述

Invasive neuromonitoring of intracranial pressure (ICP) is an important element of neurosurgical critical care that is used primarily as an indicator of adequate cerebral perfusion in patients, when clinical observation is not an option. Due to the constraint in size and the critical structures within the posterior fossa, continuous detection of postoperative pressures has been deemed desirable in patients with surgery in this region, particularly in those subjected to prolonged procedures and critical care.

The posterior fossa is an anatomically constricted compartment with narrow spaces and intracranial hypertension quickly leads to brainstem damage and neurological dysfunction. ICP in the supratentorial space not necessarily correlates with ICP in the infratentorial space. Some authors claim that it would be beneficial to measure ICP in infratentorial space after posterior fossa surgery in some cases.

In patients whose neurological examination results may be inconclusive or limited, it is valuable to have a reliable alternative method of evaluation. It is generally accepted that continuous ICP monitoring is very important to determine the timing of surgery and to prevent secondary brain damage caused by increased ICP.

There have been few clinical studies in which simultaneous pressures were recorded above and below the tentorium in patients with intracranial pathology. Yet, the relevance of infratentorial neuromonitoring remains largely unclear. So far, the placement of ICP probes in the posterior fossa seems to carry very low morbidity. Furthermore, to rely on autonomic changes, neurological deterioration, or measurements of only the supratentorial compartment as a sign of relevant complications in the posterior fossa highly narrows the temporal margin of safety for the institution of treatment. Comprehensive evaluation of possible risks of posterior fossa lesions and their treatments is crucial. Of note, immediate detection of treatment-related complications is often challenging, still being able to avoid permanent neurological sequelae. The application of the advanced neuromonitoring in the posterior fossa may be supportive in achieving this difficult goal and may provide objective assessments of procedure-related complications.

Therefore, the data generated by our prospective trial can be expected to be beneficial in individualized treatment plans. It is a relatively novel approach to intracranial multimodal neuromonitoring. The application of infratentorial probes offers potential for better understanding of lesion maturation and progression, clinical deterioration, and monitoring the effect of treatments.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • Posterior fossa lesions with anticipated prolonged neurointensive critical care
  • Patients older than 18 years
  • Informed consent if applicable (unconscious patients will be also enrolled)
  • No existing

排除标准

  • Exclusion Criteria:
  • Coagulation disorders
  • Age < 18 years
  • Pregnancy

结局指标

主要结局

Incidence of device-related events [Safety and Tolerability]

时间窗: From implementation until removing of infratentorial multimodal neuromonitoring, assessed up to 30 days

All device-related events (infections, tissue irritation, haemorrhage along device trajectory, dural leaks etc.) will be noted and reported, even if no clinical consequence will ensue

Glasgow Outcome Scale (GOS) after 6 months

时间窗: Assessed 6 months after initial treatment

GOS to asses the potential influence of infratentorial monitoring measures on clinical outcome (GOS 1-3 poor outcome; GOS 4-5 good outcome)

modified Ranking Scale (mRS) after 6 months

时间窗: Assessed 6 months after initial treatment

mRS as alternative outcome measure to asses the potential influence of infratentorial monitoring measures on clinical outcome (mRS 0-6; the higher the worse the outcome)

Correlation

时间窗: As long as neuromonitoring is indicated, assessed up to 30 days

Correlation analysis of supra- and infratentorial measures

modified Ranking Scale (mRS) after 9 months

时间窗: Assessed 9 months after initial treatment

mRS as alternative outcome measure to asses the potential influence of infratentorial monitoring measures on clinical outcome (mRS 0-6; the higher the worse the outcome)

Glasgow Outcome Scale (GOS) after 3 months

时间窗: Assessed 3 months after initial treatment

GOS to asses the potential influence of infratentorial monitoring measures on clinical outcome (GOS 1-3 poor outcome; GOS 4-5 good outcome)

Glasgow Outcome Scale (GOS) after 9 months

时间窗: Assessed 9 months after initial treatment

GOS to asses the potential influence of infratentorial monitoring measures on clinical outcome (GOS 1-3 poor outcome; GOS 4-5 good outcome)

modified Ranking Scale (mRS) after 3 months

时间窗: Assessed 3 months after initial treatment

mRS as alternative outcome measure to asses the potential influence of infratentorial monitoring measures on clinical outcome (mRS 0-6; the higher the worse the outcome)

次要结局

未报告次要终点

研究者

发起方
Medical University Innsbruck
申办方类型
Other
责任方
Sponsor

研究点 (2)

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