Measurement of Optic Nerve Sheath in Traumatic Raised Intracranial Pressure

NCT ID: NCT00783809

Last Updated: 2012-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 560 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2012-08-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Niv Sne

Director of Trauma Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Niv Sne, MD FRCSC

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences Corporation

Andrew J Healey, MD FRCPC

Role: STUDY_CHAIR

Hamilton Health Sciences Corporation

Locations

Hamilton General Hospital

Hamilton, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 28801417 (View on PubMed)

Other Identifiers

PSI-34-2008

Identifier Type: -

Identifier Source: org_study_id