Optic Nerve Ultrasound in Severe Traumatic Injury

NCT02618226 | Completed DMC FDA Device

• 3 other identifiers: HUM00092614IEC/NP-407/14.11.2014, RPR03EB019352
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury; Intracranial Hypertension

Keywords

Traumatic Brain Injury; TBI; Optic nerve ultrasound; ONUS; Intracranial pressure; ICP; Intracranial hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Therapeutic Intensity Level (TIL)

  Assessed at time of discharge from the neurotrauma intensive care unit- Average expected to be about 7 days

• In-Hospital Mortality

  At Discharge from inpatient admission- Average expected to be about 30 days

• Poor functional outcome at discharge- Glasgow Outcome Scale <4

  At Discharge from inpatient admission- Average expected to be about 30 days

Study Arms (1)

Optic nerve ultrasound

Optic nerve sheath diameter (ONSD) measurement will be performed in subjects with concomitant measurement of Intracranial Pressure (ICP) from an invasive ICP monitor. The operator measuring ONSD will be blinded to concomitant ICP.

Device: Optic nerve ultrasound

Interventions

Optic nerve ultrasound DEVICE

Measurement of ONSD with concomitant invasive ICP measurement will be performed at enrollment and at least daily for a total of 7 days. Additional measurements of ONSD may be performed at any time following any decline in Glasgow Coma Scale (GCS) score by 2+ points during the 7 day period.

Optic nerve ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe TBI in the neurotrauma ICU who meet inclusion/exclusion.

You may qualify if:

• Adult (age\>18 years) patients
• Severe TBI (GCS\<8)
• First measurement feasible \<48 hours from time of injury
• 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
• Age\>40
• Systolic blood pressure\<90
• Unilateral or Bilateral Posturing

You may not qualify if:

• Patient not expected to survive \>48 hours from the time of enrollment
• Known injury to the globe of the eye or the optic nerve
• Therapeutic Intensity Level 3 or 4 attained before ONSD measurement can be performed.

Sponsors & Collaborators

• University of Michigan: lead
• All India Institute of Medical Sciences: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

All India Institute of Medical Sciences (AIIMS)

New Delhi, India

Location

Related Publications (16)

• 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.

  PMID: 21544045 BACKGROUND

• 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. doi: 10.1097/00001199-200609000-00001.

  PMID: 16983222 BACKGROUND

• Gururaj G. Road traffic deaths, injuries and disabilities in India: current scenario. Natl Med J India. 2008 Jan-Feb;21(1):14-20.

  PMID: 18472698 BACKGROUND

• Gururaj G. Epidemiology of traumatic brain injuries: Indian scenario. Neurol Res. 2002 Jan;24(1):24-8. doi: 10.1179/016164102101199503.

  PMID: 11783750 BACKGROUND

• 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. doi: 10.1089/neu.2007.9990. No abstract available.

  PMID: 17511544 BACKGROUND

• 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. doi: 10.3171/jns.2000.92.1.0001.

  PMID: 10616075 BACKGROUND

• Rosner MJ, Daughton S. Cerebral perfusion pressure management in head injury. J Trauma. 1990 Aug;30(8):933-40; discussion 940-1. doi: 10.1097/00005373-199008000-00001.

  PMID: 2117669 BACKGROUND

• Gerber LM, Chiu YL, Carney N, Hartl 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.

  PMID: 24098983 BACKGROUND

• Farahvar A, Gerber LM, Chiu YL, Carney N, Hartl 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.

  PMID: 22900846 BACKGROUND

• 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.

  PMID: 21769456 BACKGROUND

• Geeraerts T, Launey Y, Martin L, Pottecher J, Vigue 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. doi: 10.1007/s00134-007-0797-6. Epub 2007 Aug 1.

  PMID: 17668184 BACKGROUND

• 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.

  PMID: 19098619 BACKGROUND

• 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.

  PMID: 22578001 BACKGROUND

• Hansen HC, Lagreze 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.

  PMID: 21518306 BACKGROUND

• 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. doi: 10.3171/jns.1997.87.1.0034.

  PMID: 9202262 BACKGROUND

• 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.

  PMID: 23919384 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Venkatakrishna (Krishna) Rajajee, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor, Neurosurgery and Neurology Medical Director, Neurointensive Care

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: December 1, 2015
• Study Start: January 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 5, 2021

Record last verified: 2021-01

Locations

IN (1)