A Trial of Intracranial-Pressure Monitoring in Traumatic Brain Injury

Abstract

Background Intracranial-pressure monitoring is considered the standard of care for severe traumatic brain injury and is used frequently, but the efficacy of treatment based on monitoring in improving the outcome has not been rigorously assessed. Methods We conducted a multicenter, controlled trial in which 324 patients 13 years of age or older who had severe traumatic brain injury and were being treated in intensive care units (ICUs) in Bolivia or Ecuador were randomly assigned to one of two specific protocols: guidelines-based management in which a protocol for monitoring intra-parenchymal intracranial pressure was used (pressure-monitoring group) or a protocol in which treatment was based on imaging and clinical examination (imaging–clinical examination group). The primary outcome was a composite of survival time, impaired consciousness, and functional status at 3 months and 6 months and neuro-psychological status at 6 months; neuropsychological status was assessed by an examiner who was unaware of protocol assignment. This composite measure was based on performance across 21 measures of functional and cognitive status and calculated as a percentile (with 0 indicating the worst performance, and 100 the best performance). Results There was no significant between-group difference in the primary outcome, a composite measure based on percentile performance across 21 measures of functional and cognitive status (score, 56 in the pressure-monitoring group vs. 53 in the imaging–clinical examination group; P = 0.49). Six-month mortality was 39% in the pressure-monitoring group and 41% in the imaging–clinical examination group (P = 0.60). The median length of stay in the ICU was similar in the two groups (12 days in the pressure-monitoring group and 9 days in the imaging–clinical examination group; P = 0.25), although the number of days of brain-specific treatments (e.g., administration of hyperosmolar fluids and the use of hyperventilation) in the ICU was higher in the imaging–clinical examination group than in the pressure-monitoring group (4.8 vs. 3.4, P = 0.002). The distribution of serious adverse events was similar in the two groups. Conclusions For patients with severe traumatic brain injury, care focused on maintaining monitored intracranial pressure at 20 mm Hg or less was not shown to be superior to care based on imaging and clinical examination. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT01068522.)

Declining mortality in neurocritical care patients: a cohort study in Southern Alberta over eleven years

“…Some practices, such as the use of hypothermia in TBI patients, decompressive craniectomy, and ICP monitoring, have been reported to lack efficacy at improving outcomes in preliminary clinical trials. [44][45][46] Nevertheless, our findings are in agreement with multiple observational studies suggesting that the development of specialized neurocritical care unitsusually supported by the presence of neurointensivists and utilizing evidence-based protocols-may contribute to improved patient outcomes. 28 International studies involving neurocritical care patients have suggested that there is considerable variability in outcomes between countries and individual centers.…”

Global neurotrauma research challenges and opportunities

“…Most of these evidence-based recommendations are best applied in well-funded and well-equipped neurosurgical or neurotrauma centres [15][16][17] . The recent Benchmark Evidence from South American Trials: Treatment of Intracranial Pressure (BEST Trip) trial was based on standard recommendations for randomized clinical trials in high-income countries [18][19][20][21][22] . Results were far from expected because advanced monitoring tools used to guide treatments in high-income countries were not as successful in LMICs, and discussion within the global neurotrauma scientific community emerged after the publication of this study [23][24][25][26][27] .…”

“…Thus, for LMICs, the study provided concrete information on which to base resource-allocation decisions, and documented the clinical success of a treatment approach that is sustainable in low-resource environments. Sufficiently skilled clinical staff with a better organized protocol of care could produce good recovery results in the intensive care unit (ICU) without data from an ICP monitor by using clinical assessment to manage intracranial hypertension [53][54][55][56] .…”

The Glasgow Outcome Scale — 40 years of application and refinement

“…For this reason, interest has grown in developing composite batteries that combine the GOSE with, for example, cognitive tests so as to increase sensitivity and the ability to detect subtle changes in outcome 10 . Composite endpoints have been used in several large-scale clinical trials in TBI, including studies of the impact of magnesium sulphate 67 and intracranial pressure monitoring on functional recovery following TBI 68 . Despite use of a range of outcome measures, these trials still failed to demonstrate benefits of intervention.…”