Plain English Summary
Background and study aims
Traumatic brain injury (TBI) is an injury to the brain caused by a head injury (trauma to the head). Depending on the part of the brain that is injured, it can cause changes in behaviour, physical abilities or even personality. There is a high risk of developing complications of severe brain injury such as a buildup of pressure inside the skull (increased intracranial pressure). This can starve parts of the brain of oxygen (cerebral ischaemia), leading to brain damage or even death. To prevent this, increases in intracranial pressure must be detected early. This is usually done by inserting a special tube (catheter) into the brain via a hole that is drilled in the skull or using a CT scan. Recently, ultrasound examination of the eye nerve has been found to be a useful and easy bedside tool to detect the increased intracranial pressure by measuring the diameter of the sheath around eye nerve. The aim of this study is to find out whether this technique is as accurate at measuring the pressure inside the skull as standard techniques.
Who can participate?
Adult patients on the neurocritical care unit with a severe TBI.
What does the study involve?
All participants undergo testing and monitoring for increased intracranial pressure using standard techniques. This involves having a brain scan using CT scanning and having a catheter inserted into their brains through a small hole drilled in the skull. Participants also have the diameter of the sheath surrounding the optic (eye) nerve measured using ultrasound scanning, which is used to calculate the pressure in the skull. The results are then compared in order to see how accurate the ultrasound technique is.
What are the possible benefits and risks of participating?
Participants benefit from receiving additional close monitoring while they are in hospital. There are no risks involved with participating.
Where is the study run from?
King Saud Medical City Hospital (Saudi Arabia)
When is the study starting and how long is it expected to run for?
November 2016 to August 2018
Who is funding the study?
King Saud Medical City Hospital (Saudi Arabia)
Who is the main contact?
Dr Ibrahim Soliman
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
New quality criteria of optic nerve sheath diameter measurements in the diagnosis of increased intracranial pressure in severe traumatic brain injury
Acronym
Study hypothesis
The aim of this study is to apply a new quality criteria for obtaining sonographic ONSD measurements (for diagnosis of elevated intracranial pressure) to standardise it by improving image quality and to compare such ONSD measurements to invasive intraparenchymal ICP measurements in patients with severe traumatic brain injury.
Ethics approval
Not provided at time of registration
Study design
Prospective observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
No participant information sheet available
Condition
Severe traumatic brain injury
Intervention
One hundred patients with acute severe TBI (GCS<8) will be registered in the study based on the performed power sample analysis. All patients will be evaluated clinically and by computed tomography upon inclusion. An intra-parenchymal ICP catheter will be inserted by neurosurgeons per severe TBI monitoring protocol either in the operating room or in the NCCU. Intracranial pressure will be measured using a camino intra-parenchymal catheter (Camino Laboratories, San Diego, CA, USA) will be inserted by neurosurgeons in the frontal region of each patient. ICP measurements will be continuously monitored and will be recorded within 1-2 minutes of ONSD measurement. Elevated ICP is defined as 20 mmHg or greater.
At baseline, all patients undergo a CT scan. 10-15 minutes later, the optic nerve sheath diameter will be measured for both eyes using ultrasound by a single expert sonographer who is blinded to patient identity and to invasive ICP findings. Sonographic examinations will be conducted using a Philips HD11XE (Philips Medical Systems; Bothell, WA, USA) equipped with a 10-20MHz linear transducer. All patients will be examined in the supine position. The ONSD will be measured according to the new quality criteria. In each patient, the eye with the larger ONSD will be compared to ICP (recorded within 1-2 minutes after ONSD measurement). ICP and ONSD measurements will be measured 5 times (0, 6, 12, 24 and 48 hours) per patient over 48 hours, for a total of 500 measurements.
Intervention type
Other
Phase
Drug names
Primary outcome measures
Correlation between the ONSD and ICP the ONSD measurement using the new sonographic quality criteria and the invasive ICP measured by parenchymal ICP monitor within the first 48 hours of Severe TBI
Secondary outcome measures
1. Ideal ONSD threshold value corresponding to elevated ICP is measured by the receiver operating characteristic (ROC) curves at the end of the study
2. Unfavorable outcome, that is, death, and vegetative or severe disability on the Glasgow outcome scale (GOS) at discharge from Neurocritical Care Unit (NCCU)
3. Incidence of brain death during NCCU stay is measured by dividing the number of brain death cases by the total number of study cases at the end of the study
4. NCCU average length of stay for severe TBI cases is measured by dividing the total length of stay by total number of discharges at the end of the study
Overall trial start date
01/11/2016
Overall trial end date
31/08/2018
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patient on the neurocritical care unit
2. Aged 18 years and over
3. Acute Severe TBI (Marshall Scale ≥ II and GCS ≤ 8) within the first 48 hours after trauma who has Parenchymal ICP inserted
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Orbital trauma
2. Known disease of the optic nerve
Recruitment start date
01/04/2017
Recruitment end date
30/06/2018
Locations
Countries of recruitment
Saudi Arabia
Trial participating centre
King Saud Medical City Hospital
Neurocritical care unit (NCCU)
Al Imam Turki ibn Abdullah Ibn Muhammad, Ulaishah
Riyadh
12746
Saudi Arabia
Sponsor information
Organisation
King Saud Medical City
Sponsor details
Al Imam Turki ibn Abdullah Ibn Muhammad
Ulaishah
Riyadh
12746
Saudi Arabia
+966 11 435 5555
ibrahimrefaat@hotmail.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
King Saud Medical City Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD Sharing plan:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
01/04/2019
Participant level data
Other
Results - basic reporting
Publication summary