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儿童重型创伤性脑损伤并发颅内压升高的预测:对试验设计的影响

Prediction of raised intracranial pressure complicating severe traumatic brain injury in children: implications for trial design.

作者信息

Forsyth Rob J, Parslow Roger C, Tasker Robert C, Hawley Carol A, Morris Kevin P

机构信息

School of Clinical Medical Sciences (Child Health), Sir James Spence Institute of Child Health, Royal Victoria Infirmary, Newcastle upon Tyne, UK.

出版信息

Pediatr Crit Care Med. 2008 Jan;9(1):8-14. doi: 10.1097/01.PCC.0000298759.78616.3A.

DOI:10.1097/01.PCC.0000298759.78616.3A
PMID:18477907
Abstract

OBJECTIVES

To describe current patterns of management of raised intracranial pressure (ICP) in traumatic brain injury relevant to clinician buy-in to possible randomized controlled trials of treatments of raised ICP. To examine the feasibility of early identification of children at sufficient risk of developing raised ICP to permit a uniform approach between centers to the initiation of ICP monitoring. This would permit quantification of ICP elevation and enrollment as appropriate to randomized controlled trials of raised ICP interventions.

DESIGN

Logistic regression modeling of death before pediatric intensive care unit discharge and decision tree and logistic regression of development of raised ICP through analysis of a prospectively collected, standardized, national data set.

SETTING

Pediatric intensive care units in the United Kingdom and Eire.

PATIENTS

Patients were 501 children <16 yrs of age primarily admitted to intensive care unit for management of traumatic brain injury in the United Kingdom and Eire between February 2001 and August 2003.

INTERVENTIONS

None.

MEASUREMENTS AND MAIN RESULTS

The data analyzed included demographic, acute physiologic, and cranial imaging variables. Death was associated with both raised ICP and the nonmeasurement of ICP. In a subset of 199 patients, an empirically derived decision rule predicted the development of raised ICP at any point during ICU admission with sensitivity of 73% and specificity of 74% (positive predictive value 82% and negative predictive value 63%). Logistic regression modeling performed comparably. The decision rule also predicted raised ICP in 20% of children not undergoing ICP monitoring.

CONCLUSIONS

Simple models based on early clinical data may predict the development of raised ICP sufficiently well to encourage a consistent approach between centers to initiation of ICP monitoring. We estimate studies designed to detect reductions in ICU mortality will require >320 children per arm, although this figure may be higher if more conservative assumptions are made.

摘要

目的

描述与临床医生接受颅内压(ICP)升高的可能随机对照试验相关的创伤性脑损伤中颅内压升高的当前管理模式。研究早期识别有足够风险发生颅内压升高的儿童的可行性,以便各中心在启动ICP监测方面采取统一方法。这将允许对ICP升高进行量化,并根据需要纳入ICP升高干预措施的随机对照试验。

设计

通过对前瞻性收集的标准化全国数据集进行分析,对儿科重症监护病房出院前死亡进行逻辑回归建模,并对ICP升高的发生进行决策树分析和逻辑回归。

设置

英国和爱尔兰的儿科重症监护病房。

患者

2001年2月至2003年8月期间,英国和爱尔兰主要因创伤性脑损伤入住重症监护病房的501名16岁以下儿童。

干预措施

无。

测量和主要结果

分析的数据包括人口统计学、急性生理学和颅脑成像变量。死亡与ICP升高和未测量ICP均相关。在199名患者的子集中,一个经验性得出的决策规则预测ICU住院期间任何时间ICP升高的发生,敏感性为73%,特异性为74%(阳性预测值82%,阴性预测值63%)。逻辑回归建模表现相当。该决策规则还预测了20%未进行ICP监测的儿童的ICP升高。

结论

基于早期临床数据的简单模型可能足以预测ICP升高的发生,从而鼓励各中心在启动ICP监测方面采取一致方法。我们估计,旨在检测ICU死亡率降低的研究每组将需要超过320名儿童,尽管如果做出更保守的假设,这个数字可能会更高。

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Re-orientation of clinical research in traumatic brain injury: report of an international workshop on comparative effectiveness research.颅脑创伤临床研究的再定位:比较有效性研究国际研讨会报告。
J Neurotrauma. 2012 Jan 1;29(1):32-46. doi: 10.1089/neu.2010.1599. Epub 2011 Aug 29.
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Traumatic brain injury in children: recent advances in management.
儿童创伤性脑损伤:管理方面的最新进展
Indian J Pediatr. 2008 Nov;75(11):1159-65. doi: 10.1007/S12098-008-0240-1. Epub 2009 Jan 7.