Randall M. Chesnut, M.D., Nancy Temkin, Ph.D., Nancy Carney, Ph.D., Sureyya Dikmen, Ph.D., Carlos Rondina, M.D., Walter Videtta, M.D., Gustavo Petroni, M.D., Silvia Lujan, M.D., Jim Pridgeon, M.H.A., Jason Barber, M.S., Joan Machamer, M.A., Kelley Chaddock, B.A., Juanita M. Celix, M.D., Marianna Cherner, Ph.D., and Terence Hendrix, B.A.
N Engl J Med 367:2471-2481, 2012 DOI: 10.1056/NEJMoa1207363
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 intraparenchymal 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 neuropsychological 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.)
Address reprint requests to Dr. Chesnut at the University of Washington, Harborview Medical Center, Department of Neurological Surgery, 325 Ninth Ave., Box 359766, Seattle, WA 98104, or at This e-mail address is being protected from spambots. You need JavaScript enabled to view it .
Comments (5)
written by andrewtarnaris, January 20, 2013
written by Andyneuro, January 21, 2013
written by Efren Herrera, February 04, 2013
It is difficult to explain how come that ICP recording or non recording makes no difference upon the final outcome. These findings are so relevant that the sutdy deserves repetition in Canada or the USA if possible.
The authors conclude that care focused on maintaining intracranial pressure at 20 mmHg or less was not superior to care based on imaging and clinical examination.