Skip to content

Intracranial Pressure and Optic Nerve Sheath Diameter With CLOSED Bundle

Correlation Between Intracranial Pressure and Optic Nerve Sheath Diameter Measured With CLOSED Bundle in Patients With Acute Brain Injury: Multicenter Observational Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06057155
Acronym
CLOSED
Enrollment
150
Registered
2023-09-28
Start date
2024-05-01
Completion date
2026-06-01
Last updated
2024-03-06

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

Conditions

Hypertension Intracranial, Intra Cerebral Hemorrhage, Stroke, Ischemic, Subarachnoid Hemorrhage, Aneurysmal, Trauma, Brain

Keywords

optic nerve sheath diameter, ultrasonography, Hypertension Intracranial, neuro monitoring

Brief summary

The design of the present study will be a multicenter prospective observational protocol. Approximately 100 patients will be recruited over the 24-month period with Acute Brain Injury (trauma brain injury, intracerebral hemorrhage, subarachnoid hemorrhage, ischemic stroke), who in their acute phase of intensive care unit require placement of a catheter capable of monitoring intracranial pressure (intra parenchymal catheter or external ventricular shunt). In addition to all the intensive care provided by the most recent guidelines, patients will undergo measurement of optic nerve sheath diameter through ultrasonography. At least, three measurements will be performed within the first 3 hours after admission, within the first 24-48 hours, and at each invasive intracranial pressure value greater than 18 cmH2O. Those patients with intracranial pressure values greater than 35 mmHg. At the first intracranial pressure measurement, patients with eyeball disease or trauma will be excluded. Measurements will be performed following the CLOSED bundle. Analysis of the results will include correlation between the invasive pressure values and the mean value of optic nerve sheath diameter measurements in the two projections (sagittal and transverse). In addition, the correlation of the absolute value of invasive pressure detected with the ratio of the optic nerve sheath diameter measurement to the eyeball diameter measured always ultrasound will be sought.

Interventions

DIAGNOSTIC_TESTultrasound optic nerve sheath diameter assessment

ultrasound optic nerve sheath diameter assessment

Sponsors

IRCCS Istituto delle Scienze Neurologiche di Bologna
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

acute brain injury patients with an invasive intra-cranial pressure monitoring \-

Exclusion criteria

patients affected by disease or trauma of eye ball patients or relatives that don't want to participate to the study \-

Design outcomes

Primary

MeasureTime frameDescription
correlation between invasive ICP/ONSD3, 24, 48 hours after admissioncorrelation between invasive intra-cranial pression assessment and ultasound ONSD assessment

Secondary

MeasureTime frameDescription
correlation between invasive intra-cranial pression assessment and ultasound ratio of ONSD assessment and eyeball transverse diameter3, 24, 48 hours after admissioncorrelation between invasive ICP/(ONSD/ETD)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026