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

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.