Traumatic Brain InjuryNCT03795896
Ocular Ultrasonography as a Tool for Monitoring the Management of Traumatic Brain Injury
A study testing Optic nerve sheath diameter in people with Traumatic Brain Injury, run by Mansoura University Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Optic nerve sheath diameter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2018to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with traumatic brain injury
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ocular Ultrasonography in Assessing Severity and Management of Increased Intracranial Pressure in Traumatic Brain Injury
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
Read the 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
- Conditions
- Traumatic Brain Injury
- Being tested
- Optic nerve sheath diameter
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optic nerve sheath diameterDiagnostic test
Also called ONSD
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
| Study group | Role | What they receive |
|---|---|---|
| Optic nerve sheath diameter | Experimental | 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 Receives: Diagnostic Test: Optic nerve sheath diameter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from 20 minutes before mannitol therapy (basal reading) till 48 hours after the end of mannitol infusion
Secondary outcomes (2)
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
Measured: from 20 minutes before mannitol therapy (basal reading ) till 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
Measured: from 20 minutes before mannitol therapy(basal reading) till 48 hours after the end of mannitol infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start1 Sep 2018
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective observational study
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelraouf Elsharkawy, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795896
- Sponsor's protocol ID
- Ms/15.05.88
- Status last verified
- Jan 2019
- First submitted
- 1 Jan 2019
- Last updated
- 8 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Ultrasonography in Assessing Severity and Management of Increased Intracranial Pressure in Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03795896
- Acronym / sponsor ID
- Ms/15.05.88
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mansoura University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 8 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective observational study
| Arm | Type | Receives |
|---|---|---|
| Optic nerve sheath diameter | Experimental | Diagnostic Test: Optic nerve sheath diameterThe 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 |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with traumatic brain injury
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optic nerve sheath diameterAlso: ONSDThe 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 | Diagnostic test | Optic nerve sheath diameter |
Primary outcome
Assessing the changes in the intracranial pressure
Time frame: from 20 minutes before mannitol therapy (basal reading) till 48 hours after the end of mannitol infusion
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
2 secondary outcomes
Assessing the changes in the heart rate
Time frame: from 20 minutes before mannitol therapy (basal reading ) till 48 hours after the end of mannitol infusion
Assessing the changes in the mean arterial pressure
Time frame: from 20 minutes before mannitol therapy(basal reading) till 48 hours after the end of mannitol infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optic nerve sheath diameter in people with Traumatic Brain Injury, run by Mansoura University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the changes in the intracranial pressure (time frame: from 20 minutes before mannitol therapy (basal reading) till 48 hours after the end of mannitol infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019.