Ocular Ultrasonography as a Tool for Monitoring the Management of Traumatic Brain Injury
Primary Purpose
Traumatic Brain Injury
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Optic nerve sheath diameter
Sponsored by
About this trial
This is an interventional diagnostic trial for Traumatic Brain Injury
Eligibility Criteria
Inclusion Criteria:
- Patients with traumatic brain injury
Exclusion Criteria:
- Patients with history of optic neuritis
- past history of eye trauma
- patient with optic nerve trauma
- patient with history of arachnoid cyst of the optic nerve
- high myopic patients
- patients with cavernous sius mass
Sites / Locations
- Reem Abdelraouf Elsharkawy
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Optic nerve sheath diameter
Arm Description
The intracranial pressure will be measured by optic nerve sheath diameter while the patient in supine position with 30 -degree bed position .The linear probe in the two -dimensional mode will be placed gently on the upper eyelid without pressure .In linear horizontal orientation for both right and left optic nerve sheath will be measured
Outcomes
Primary Outcome Measures
Assessing the changes in the intracranial pressure
It will be monitored and recorded the changes in intracranial pressure to the mannitol therapy .Basal (before mannitol therapy).20 minutes after the end of mannitol infusion ,2 hours ,6 hours,12 hours ,24 hours and 48 hours after the end of mannitol infusion
Secondary Outcome Measures
Assessing the changes in the heart rate
It will be recorded basal (before mannitol therapy).20 minutes after the end of mannitol infusion ,2 hours ,6 hours,12 hours ,24 hours and 48 hours after the end of mannitol infusion
Assessing the changes in the mean arterial pressure
It will be calculated according to the formula systolic blood pressure+2(diastolic blood pressure)recorded basal (before mannitol therapy).20 minutes after the end of mannitol infusion ,2 hours ,6 hours,12 hours ,24 hours and 48 hours after the end of mannitol infusion
Full Information
NCT ID
NCT03795896
First Posted
January 1, 2019
Last Updated
January 5, 2019
Sponsor
Mansoura University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03795896
Brief Title
Ocular Ultrasonography as a Tool for Monitoring the Management of Traumatic Brain Injury
Official Title
Ocular Ultrasonography in Assessing Severity and Management of Increased Intracranial Pressure in Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
November 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Raised intracranial pressure (ICP) is a common and life threatening condition especially in patients with traumatic brain injury.There are many methods for monitoring the increased (ICP) either invasive or non- invasive ,but the gold standard is invasive method. Optic nerve sheath ultrasonography provides a very promising bedside tool for detection of increased ICP. This study will monitor the dynamic changes of intracranial pressure by optic nerve sheath diameter (ONSD) in response to mannitol osmotherapy
Detailed Description
Traumatic brain injury is the main cause of increased intracranial pressure (ICP) in the intensive care .
There are multiple methods for monitoring the raised ICP either invasive or non-invasive.The gold standard is the invasive devices because it is more accurate and reliable .However ,it requires a surgical intervention which has many hazards such as (infection ,hemorrhage,malfunction ).
Optic nerve sheath ultrasonography is a promising bedside tool for detection of increased ICP. The optic nerve is surrounded by cerebro-spinal fluid ,thus if the circulation of cerebro-spinal fluid not blocked ,an increase in ICP will be transmitted through the subarachnoid space around the optic nerve within the nerve sheath especially the retro-bulbar segment.
The study will be conducted to monitor the dynamic changes of intracranial pressure by optic nerve sheath diameter (ONSD) in response to mannitol osmotherapy as a primary outcome and secondary to evaluate the efficacy of ONSD in assessing the severity of the disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective observational study
Masking
None (Open Label)
Masking Description
No masking
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Optic nerve sheath diameter
Arm Type
Experimental
Arm Description
The intracranial pressure will be measured by optic nerve sheath diameter while the patient in supine position with 30 -degree bed position .The linear probe in the two -dimensional mode will be placed gently on the upper eyelid without pressure .In linear horizontal orientation for both right and left optic nerve sheath will be measured
Intervention Type
Diagnostic Test
Intervention Name(s)
Optic nerve sheath diameter
Other Intervention Name(s)
ONSD
Intervention Description
The intracranial pressure will be measured by the optic nerve sheath diameter and after giving the mannitol osmotherapy the intracranial pressure will be monitored by the optic nerve sheath diameter
Primary Outcome Measure Information:
Title
Assessing the changes in the intracranial pressure
Description
It will be monitored and recorded the changes in intracranial pressure to the mannitol therapy .Basal (before mannitol therapy).20 minutes after the end of mannitol infusion ,2 hours ,6 hours,12 hours ,24 hours and 48 hours after the end of mannitol infusion
Time Frame
from 20 minutes before mannitol therapy (basal reading) till 48 hours after the end of mannitol infusion
Secondary Outcome Measure Information:
Title
Assessing the changes in the heart rate
Description
It will be recorded basal (before mannitol therapy).20 minutes after the end of mannitol infusion ,2 hours ,6 hours,12 hours ,24 hours and 48 hours after the end of mannitol infusion
Time Frame
from 20 minutes before mannitol therapy (basal reading ) till 48 hours after the end of mannitol infusion
Title
Assessing the changes in the mean arterial pressure
Description
It will be calculated according to the formula systolic blood pressure+2(diastolic blood pressure)recorded basal (before mannitol therapy).20 minutes after the end of mannitol infusion ,2 hours ,6 hours,12 hours ,24 hours and 48 hours after the end of mannitol infusion
Time Frame
from 20 minutes before mannitol therapy(basal reading) till 48 hours after the end of mannitol infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with traumatic brain injury
Exclusion Criteria:
Patients with history of optic neuritis
past history of eye trauma
patient with optic nerve trauma
patient with history of arachnoid cyst of the optic nerve
high myopic patients
patients with cavernous sius mass
Facility Information:
Facility Name
Reem Abdelraouf Elsharkawy
City
Mansourah
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
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Ocular Ultrasonography as a Tool for Monitoring the Management of Traumatic Brain Injury
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