Traumatic Brain Injury Clinical Trial
— ONUS-TBIOfficial title:
Diagnostic Accuracy of Optic Nerve Ultrasound for the Detection of Intracranial Hypertension and Prediction of Therapeutic Intensity Level and Mortality Following Severe Traumatic Brain Injury (ONUS-TBI): a Prospective Blinded Study
Verified date | January 2021 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Prospective study of diagnostic accuracy of optic nerve sheath diameter measurement (index study) in traumatic brain injury with simultaneous invasive intracranial pressure monitoring as the reference standard.
Status | Completed |
Enrollment | 117 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Adult (age>18 years) patients 2. Severe TBI (GCS<8) 3. First measurement feasible <48 hours from time of injury 4. Clinical decision has been made to place an invasive ICP monitor, based on the recommendations of the Brain Trauma Foundation. I. GCS<8 and Abnormal CT brain OR II. GCS<8 and Normal CT brain PLUS any 2 of the following 1. Age>40 2. Systolic blood pressure<90 3. Unilateral or Bilateral Posturing Exclusion Criteria: 1. Patient not expected to survive >48 hours from the time of enrollment 2. Known injury to the globe of the eye or the optic nerve 3. Therapeutic Intensity Level 3 or 4 attained before ONSD measurement can be performed. |
Country | Name | City | State |
---|---|---|---|
India | All India Institute of Medical Sciences (AIIMS) | New Delhi |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | All India Institute of Medical Sciences, New Delhi, National Institute for Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health (NIH) |
India,
Brain Trauma Foundation; American Association of Neurological Surgeons; Congress of Neurological Surgeons; Joint Section on Neurotrauma and Critical Care, AANS/CNS, Bratton SL, Chestnut RM, Ghajar J, McConnell Hammond FF, Harris OA, Hartl R, Manley GT, Nemecek A, Newell DW, Rosenthal G, Schouten J, Shutter L, Timmons SD, Ullman JS, Videtta W, Wilberger JE, Wright DW. Guidelines for the management of severe traumatic brain injury. VI. Indications for intracranial pressure monitoring. J Neurotrauma. 2007;24 Suppl 1:S37-44. Erratum in: J Neurotrauma. 2008 Mar;25(3):276-8. multiple author names added. — View Citation
Coronado VG, Xu L, Basavaraju SV, McGuire LC, Wald MM, Faul MD, Guzman BR, Hemphill JD; Centers for Disease Control and Prevention (CDC). Surveillance for traumatic brain injury-related deaths--United States, 1997-2007. MMWR Surveill Summ. 2011 May 6;60(5):1-32. — View Citation
Dubourg J, Messerer M, Karakitsos D, Rajajee V, Antonsen E, Javouhey E, Cammarata A, Cotton M, Daniel RT, Denaro C, Douzinas E, Dubost C, Berhouma M, Kassai B, Rabilloud M, Gullo A, Hamlat A, Kouraklis G, Mannanici G, Marill K, Merceron S, Poularas J, Ristagno G, Noble V, Shah S, Kimberly H, Cammarata G, Moretti R, Geeraerts T. Individual patient data systematic review and meta-analysis of optic nerve sheath diameter ultrasonography for detecting raised intracranial pressure: protocol of the ONSD research group. Syst Rev. 2013 Aug 6;2:62. doi: 10.1186/2046-4053-2-62. — View Citation
Farahvar A, Gerber LM, Chiu YL, Carney N, Härtl R, Ghajar J. Increased mortality in patients with severe traumatic brain injury treated without intracranial pressure monitoring. J Neurosurg. 2012 Oct;117(4):729-34. doi: 10.3171/2012.7.JNS111816. Epub 2012 Aug 17. — View Citation
Geeraerts T, Launey Y, Martin L, Pottecher J, Vigué B, Duranteau J, Benhamou D. Ultrasonography of the optic nerve sheath may be useful for detecting raised intracranial pressure after severe brain injury. Intensive Care Med. 2007 Oct;33(10):1704-11. Epub 2007 Aug 1. — View Citation
Gerber LM, Chiu YL, Carney N, Härtl R, Ghajar J. Marked reduction in mortality in patients with severe traumatic brain injury. J Neurosurg. 2013 Dec;119(6):1583-90. doi: 10.3171/2013.8.JNS13276. Epub 2013 Oct 8. — View Citation
Gururaj G. Epidemiology of traumatic brain injuries: Indian scenario. Neurol Res. 2002 Jan;24(1):24-8. Review. — View Citation
Gururaj G. Road traffic deaths, injuries and disabilities in India: current scenario. Natl Med J India. 2008 Jan-Feb;21(1):14-20. Review. — View Citation
Hansen HC, Helmke K. Validation of the optic nerve sheath response to changing cerebrospinal fluid pressure: ultrasound findings during intrathecal infusion tests. J Neurosurg. 1997 Jul;87(1):34-40. — View Citation
Hansen HC, Lagrèze W, Krueger O, Helmke K. Dependence of the optic nerve sheath diameter on acutely applied subarachnoidal pressure - an experimental ultrasound study. Acta Ophthalmol. 2011 Sep;89(6):e528-32. doi: 10.1111/j.1755-3768.2011.02159.x. Epub 2011 Apr 21. — View Citation
Juul N, Morris GF, Marshall SB, Marshall LF. Intracranial hypertension and cerebral perfusion pressure: influence on neurological deterioration and outcome in severe head injury. The Executive Committee of the International Selfotel Trial. J Neurosurg. 2000 Jan;92(1):1-6. — View Citation
Langlois JA, Rutland-Brown W, Wald MM. The epidemiology and impact of traumatic brain injury: a brief overview. J Head Trauma Rehabil. 2006 Sep-Oct;21(5):375-8. — View Citation
Moretti R, Pizzi B. Optic nerve ultrasound for detection of intracranial hypertension in intracranial hemorrhage patients: confirmation of previous findings in a different patient population. J Neurosurg Anesthesiol. 2009 Jan;21(1):16-20. doi: 10.1097/ANA.0b013e318185996a. — View Citation
Rajajee V, Fletcher JJ, Rochlen LR, Jacobs TL. Comparison of accuracy of optic nerve ultrasound for the detection of intracranial hypertension in the setting of acutely fluctuating vs stable intracranial pressure: post-hoc analysis of data from a prospective, blinded single center study. Crit Care. 2012 May 11;16(3):R79. doi: 10.1186/cc11336. — View Citation
Rajajee V, Vanaman M, Fletcher JJ, Jacobs TL. Optic nerve ultrasound for the detection of raised intracranial pressure. Neurocrit Care. 2011 Dec;15(3):506-15. doi: 10.1007/s12028-011-9606-8. — View Citation
Rosner MJ, Daughton S. Cerebral perfusion pressure management in head injury. J Trauma. 1990 Aug;30(8):933-40; discussion 940-1. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intracranial Pressure (ICP) >25mmHg | Accuracy of ONSD measurement (index test) compared to the reference standard- ICP>25mmHg on concomitant invasive monitoring | Days 1-7 | |
Secondary | Therapeutic Intensity Level (TIL) | Highest Therapeutic Intensity Level attained during the ICU admission | Assessed at time of discharge from the neurotrauma intensive care unit- Average expected to be about 7 days | |
Secondary | In-Hospital Mortality | All-cause mortality during the inpatient admission | At Discharge from inpatient admission- Average expected to be about 30 days | |
Secondary | Poor functional outcome at discharge- Glasgow Outcome Scale <4 | Moderate or low disability at the time of discharge | At Discharge from inpatient admission- Average expected to be about 30 days |
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