TY - JOUR
T1 - Traumatic brain injury in latin America
T2 - Lifespan analysis randomized control trial protocol
AU - Chesnut, Randall M.
AU - Temkin, Nancy
AU - Carney, Nancy
AU - Dikmen, Sureyya
AU - Pridgeon, Jim
AU - Barber, Jason
AU - Celix, Juanita M.
AU - Chaddock, Kelley
AU - Cherner, Marianna
AU - Hendrix, Terence
AU - Lujan, Silvia
AU - MacHamer, Joan
AU - Petroni, Gustavo
AU - Rondina, Carlos
AU - Videtta, Walter
PY - 2012/12
Y1 - 2012/12
N2 - BACKGROUND: Although in the developed world the intracranial pressure (ICP) monitor is considered the standard of care for patients with severe traumatic brain injury (TBI), its usefulness to direct treatment decisions has never been tested rigorously. OBJECTIVE: The primary focus was to conduct a high-quality, randomized, controlled trial to determine whether ICP monitoring used to direct TBI treatment improves patient outcomes. By providing education, equipment, and structure, the project will enhance the research capacity of the collaborating investigators and will foster the collaborations established during earlier studies. METHODS: Study centers were selected that routinely treated ICP based on clinical examination and computed tomography imaging using internal protocols. We randomized patients to either an ICP monitor group or an imaging and clinical examination group. Treatment decisions for the ICP monitor group are guided by ICP monitoring based on established guidelines. Treatment decisions for the imaging and clinical examination group are made using a single protocol derived from those previously being used at those centers. EXPECTED OUTCOMES: There are 2 study hypotheses: (1) patients with severe TBI whose acute care treatment is managed using ICP monitors will have improved outcomes and 2) incorporating ICP monitoring in the care of patients with severe TBI will minimize complications and decrease length of intensive care unit stay. DISCUSSION: This clinical trial tests the effectiveness of a management protocol based on technology considered pivotal to brain trauma treatment in the developed world: the ICP monitor. A randomized, controlled trial of ICP monitoring has never been performed-a critical gap in the evidence base that supports the role of ICP monitoring in TBI care. As such, the results of this randomized, controlled trial will have global implications regardless of the level of development of the trauma system.
AB - BACKGROUND: Although in the developed world the intracranial pressure (ICP) monitor is considered the standard of care for patients with severe traumatic brain injury (TBI), its usefulness to direct treatment decisions has never been tested rigorously. OBJECTIVE: The primary focus was to conduct a high-quality, randomized, controlled trial to determine whether ICP monitoring used to direct TBI treatment improves patient outcomes. By providing education, equipment, and structure, the project will enhance the research capacity of the collaborating investigators and will foster the collaborations established during earlier studies. METHODS: Study centers were selected that routinely treated ICP based on clinical examination and computed tomography imaging using internal protocols. We randomized patients to either an ICP monitor group or an imaging and clinical examination group. Treatment decisions for the ICP monitor group are guided by ICP monitoring based on established guidelines. Treatment decisions for the imaging and clinical examination group are made using a single protocol derived from those previously being used at those centers. EXPECTED OUTCOMES: There are 2 study hypotheses: (1) patients with severe TBI whose acute care treatment is managed using ICP monitors will have improved outcomes and 2) incorporating ICP monitoring in the care of patients with severe TBI will minimize complications and decrease length of intensive care unit stay. DISCUSSION: This clinical trial tests the effectiveness of a management protocol based on technology considered pivotal to brain trauma treatment in the developed world: the ICP monitor. A randomized, controlled trial of ICP monitoring has never been performed-a critical gap in the evidence base that supports the role of ICP monitoring in TBI care. As such, the results of this randomized, controlled trial will have global implications regardless of the level of development of the trauma system.
KW - Clinical research protocol
KW - Craniocerebral trauma
KW - Intracranial pressure
KW - Randomized controlled trial
UR - http://www.scopus.com/inward/record.url?scp=84870066987&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84870066987&partnerID=8YFLogxK
U2 - 10.1227/NEU.0b013e31827276b7
DO - 10.1227/NEU.0b013e31827276b7
M3 - Article
C2 - 22986600
AN - SCOPUS:84870066987
SN - 0148-396X
VL - 71
SP - 1055
EP - 1063
JO - Neurosurgery
JF - Neurosurgery
IS - 6
ER -