Brain Densitometric Assessment With Axial Computerized Tomography After Severe Brain Trauma.
研究概览
地位
详细说明
Quantitative analysis of brain and structures in it, in terms of volume, weight and density, in patients with severe brain trauma, using MALUNA dedicated software to process DICOM images.
- st endpoint: compare these data with those obtained by CT scans analysis of patients that recur to this kind of diagnostic investigation for non-traumatic events and with negative diagnostic related to cerebral pathological implication.
- nd endpoint: relate data obtained with clinical evaluation of the patient (cerebral physiology and outcome)
- rd endpoint: evaluate differences in terms of volume, weight and density of brain and its structures, between patients with diffuse cerebral injury and those with localized lesions.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Varese、意大利、21100
- Azienda ospedaliera ospedale Circolo e Fondazione Macchi
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Male and female, any ethnic group
- Patient with severe brain trauma (GCS < 8)
- Need of mechanical ventilation
- Clinical need of urgent CT study of brain.
- Need of clinical control of CT study of brain within first 72 hours from event
- Informed consent obtained from solicitor, due to the fact that patient is
Exclusion Criteria:
- Age minor than 18 yrs old at hospitalization day
- Cardiac arrest pre-hospital or in-hospital and post-anoxic coma
- Non traumatic coma
- Exaggerated ingestion of depressors of central nervous system
- Documented abuse of narcotic drugs;
- Documented abuse of alcohol
学习计划
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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The evaluation of volumetrical and densitometric data of brain tissue of patients with severe brain trauma
大体时间：Participants will be followed for 8 days
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Participants will be followed for 8 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The evaluation of consciousness.
大体时间：Participants will be followed for 8 days
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During the observation are evaluated: • Glasgow Coma Scale (GCS). |
Participants will be followed for 8 days
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The evaluation of clinical conditions.
大体时间：Participants will be followed for 8 days
|
During the observation are evaluated multiparametric arterial and venous gas analysis : partial pressure of oxygen in arterial blood(PaO2); partial pressure of carbon dioxide in the arterial blood (PaCO2); cerebral venous oxygen saturation (SjO2); arterial oxygen saturation (SaO2); measure of the acidity or basicity of an aqueous solution (pH); base excess (B.E.); bicarbonate ion (HCO3-); sodium ion (Na+); potassium ion (K+); glycemia; blood concentration of hemoglobin(Hb); hematocrit (Ht). |
Participants will be followed for 8 days
|
|
The evaluation of brain pressures
大体时间：Participants will be followed for 8 days
|
During the observation are evaluating: • Intracranial Cerebral Pressure (ICP) if monitored and perfusional cerebral pressure(PCP); |
Participants will be followed for 8 days
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The evaluation of cardiac monitoring.
大体时间：Participants will be followed for 8 days
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During the observation are evaluating: • Mean arterial pressure (MAP), cardiac frequency (FC), body temperature, water balance, diuresis; |
Participants will be followed for 8 days
|
合作者和调查者
调查人员
- 首席研究员：Paolo MD Severgnini, Prof.、Università degli Studi dell'Insubria, Varese, Italia
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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