Measurement of Optic Nerve Sheath in Traumatic Raised Intracranial Pressure

NCT00783809 | Unknown

• 1 other identifier: PSI-34-2008
• Study Type: observational
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

Trauma patients are at risk for serious head trauma. The consequences of serious head trauma are often life altering. Currently, the only method available to rapidly assess the severity of head injury and need for neurosurgical intervention is the CT scan. This time consuming test requires transportation of a potentially unstable patient to the CT scanner. The investigators goal in traumatic brain injury is to identify early those patients who may require neurosurgical intervention. Brain swelling (elevated intracranial pressure) is transmitted to the eye and this can be measured with ultrasound. The investigators hypothesis is that this test will rule out significant elevations in intracranial pressure and perform as well as CT scan in doing this. The investigators study aims to demonstrate that ultrasound of the optic nerve is as good as CT scan in ruling out clinically significant elevations in pressure within the brain. After consent has been obtained, any trauma patient who has an indication to undergo CT scan of the brain will also undergo ultrasound of the eye. A radiologist will then review the CT scans to determine if signs of elevated intracranial pressure are present. The investigators hope to demonstrate that a bedside ultrasound performed in the trauma suite is reliable for ruling out the possibility of elevated intracranial pressure. \*\*Update August 2009\*\* Currently, deferred consent has been obtained from our REB allowing us to defer consent for this intervention of minimal risk. As well, REB has also approved phone consent in the interim.

Conditions

Traumatic Brain Injury

Keywords

intracranial pressure; intracranial hypertension; ultrasound; emergency; traumatic brain injury; ocular ultrasound

Outcome Measures

Primary Outcomes (1)

• Elevation in intracranial pressure as estimated by CT scan or ICP monitor

  Immediate

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who present to the emergency department with suspected closed head injury as a result of blunt trauma and require CT head

You may qualify if:

• Age greater or equal to 16 involved in blunt trauma.
• Patient is to undergo a CT of the head to evaluate suspected closed head injury
• Consent and ultrasound can be preformed within 1 hour before or after CT of the head

You may not qualify if:

• Penetrating trauma to the head or significant ocular trauma
• Patients not expected to survive transfer out of the emergency room department
• Patient is too unstable to undergo a CT of the head or ultrasound of the optic nerve

Sponsors & Collaborators

• McMaster University: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

Location

Related Publications (1)

• Koziarz A, Sne N, Kegel F, Alhazzani W, Nath S, Badhiwala JH, Rice T, Engels P, Samir F, Healey A, Kahnamoui K, Banfield L, Sharma S, Reddy K, Hawryluk GWJ, Kirkpatrick AW, Almenawer SA. Optic nerve sheath diameter sonography for the diagnosis of increased intracranial pressure: a systematic review and meta-analysis protocol. BMJ Open. 2017 Aug 11;7(8):e016194. doi: 10.1136/bmjopen-2017-016194.

  PMID: 28801417 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Intracranial Hypertension; Emergencies

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Niv Sne, MD FRCSC

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

• Andrew J Healey, MD FRCPC

  Hamilton Health Sciences Corporation

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Trauma Research

Study Record Dates

• First Submitted: October 31, 2008
• First Posted: November 3, 2008
• Study Start: October 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: April 27, 2012

Record last verified: 2012-04

Locations

CA (1)