New quality criteria of eye nerve sheath diameter measurements in the diagnosis of increased pressure inside the skull in severe brain trauma

ISRCTN ISRCTN95355585
DOI https://doi.org/10.1186/ISRCTN95355585
Secondary identifying numbers N/A
Submission date
07/03/2017
Registration date
04/04/2017
Last edited
18/02/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Ibrahim Soliman
Scientific

Neuro Critical Care Unit (NCCU)
King Saud Medical City (KSMC)
Al Imam Turki ibn Abdullah Ibn Muhammad, Ulaishah
Riyadh
12746
Saudi Arabia

Study information

Study designProspective observational cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet No participant information sheet available
Scientific titleNew quality criteria of optic nerve sheath diameter measurements in the diagnosis of increased intracranial pressure in severe traumatic brain injury
Study objectivesThe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSevere traumatic brain injury
InterventionOne 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 typeOther
Primary outcome measureCorrelation 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 measures1. 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 study start date01/11/2016
Completion date31/08/2018

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants100
Key inclusion criteria1. 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
Key exclusion criteria1. Orbital trauma
2. Known disease of the optic nerve
Date of first enrolment01/04/2017
Date of final enrolment30/06/2018

Locations

Countries of recruitment

  • Saudi Arabia

Study 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

King Saud Medical City
Hospital/treatment centre

Al Imam Turki ibn Abdullah Ibn Muhammad
Ulaishah
Riyadh
12746
Saudi Arabia

Phone +966 11 435 5555
Email ibrahimrefaat@hotmail.com
Website https://www.ksmc.med.sa/en/Pages/default.aspx
ROR logo "ROR" https://ror.org/03aj9rj02

Funders

Funder type

Hospital/treatment centre

King Saud Medical City Hospital

No information available

Results and Publications

Intention to publish date01/04/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing planThe datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 30/04/2018 18/02/2022 Yes No

Editorial Notes

18/02/2022: Publication reference added.