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

New quality criteria of optic nerve sheath diameter measurements in the diagnosis of increased intracranial pressure in severe traumatic brain injury

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN95355585

Enrollment

100

Registered

2017-04-04

Start date

2017-04-01

Completion date

Unknown

Last updated

2022-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe traumatic brain injury Nervous System Diseases Severe traumatic brain injury

Interventions

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 up

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, th

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Orbital trauma 2. Known disease of the optic nerve

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Saudi Arabia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026