Traumatic Brain Injury in Latin America: Lifespan Analysis Randomized Control Trial Protocol

被引：8

作者：

Chesnut, Randall M. ^{[1
,2
]}

Temkin, Nancy ^{[1
,3
]}

Carney, Nancy ^{[5
]}

Dikmen, Sureyya ^{[1
,4
]}

Pridgeon, Jim ^{[1
]}

Barber, Jason ^{[1
]}

Celix, Juanita M. ^{[1
]}

Chaddock, Kelley ^{[1
]}

Cherner, Marianna ^{[6
]}

Hendrix, Terence ^{[1
,7
]}

Lujan, Silvia ^{[8
]}

Machamer, Joan ^{[4
]}

Petroni, Gustavo ^{[8
]}

Rondina, Carlos ^{[8
]}

Videtta, Walter ^{[9
]}

机构：

[1] Univ Washington, Harborview Med Ctr, Dept Neurol Surg, Seattle, WA 98104 USA

[2] Univ Washington, Harborview Med Ctr, Dept Orthopaed & Sports Med, Seattle, WA 98104 USA

[3] Univ Washington, Harborview Med Ctr, Dept Biostat, Seattle, WA 98104 USA

[4] Univ Washington, Harborview Med Ctr, Dept Rehabil Med, Seattle, WA 98104 USA

[5] Oregon Hlth & Sci Univ, Dept Med Informat & Clin Epidemiol, Portland, OR 97201 USA

[6] Univ Calif San Diego, Dept Psychiat, La Jolla, CA 92093 USA

[7] Univ Calif San Diego, HIV Neurobehav Res Programs, La Jolla, CA 92093 USA

[8] Hosp Emergencias, Santa Fe, Argentina

[9] Hosp Nacl, Buenos Aires, DF, Argentina

来源：

NEUROSURGERY | 2012年 / 71卷 / 06期

关键词：

Craniocerebral trauma; Clinical research protocol; Intracranial pressure; Randomized controlled trial; SCALE; FLUENCY; NORMS;

D O I：

10.1227/NEU.0b013e31827276b7

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

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 performeda 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.

引用

页码：1055 / 1063

页数：9

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