Measurement of Optic Nerve Sheath in Traumatic Raised Intracranial Pressure

Traumatic Brain Injury Clinical Trial

— MOONSTRIP  

Official title:

Measurement of Optic Nerve Sheath in Traumatic Raised Intracranial Pressure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00783809
• Other study ID #: PSI-34-2008
• Status: Active, not recruiting
• Phase: N/A
• First received: October 31, 2008
• Last updated: April 26, 2012
• Start date: October 2008
• Est. completion date: August 2012

Study information

• Verified date: April 2012
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 560
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Intracranial Hypertension
• Traumatic Brain Injury

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elevation in intracranial pressure as estimated by CT scan or ICP monitor		Immediate	No