Clinical trial NCT06057155: Intracranial Pressure and Optic Nerve Sheath Diameter With CLOSED Bundle
Official title: Correlation Between Intracranial Pressure and Optic Nerve Sheath Diameter Measured With CLOSED Bundle in Patients With Acute Brain Injury: Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Intra Cerebral Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal
Trauma, Brain
Hypertension Intracranial
Stroke, Ischemic
Keywords: optic nerve sheath diameter
ultrasonography
Hypertension Intracranial
neuro monitoring
Lead sponsor: IRCCS Istituto delle Scienze Neurologiche di Bologna
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: acute brain injury patients at risk of intra-cranial hypertension

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.


Eligibility criteria: 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

-

Primary outcomes:
measure: correlation between invasive ICP/ONSD
timeFrame: 3, 24, 48 hours after admission
Secondary outcomes:
measure: correlation between invasive intra-cranial pression assessment and ultasound ratio of ONSD assessment and eyeball transverse diameter
timeFrame: 3, 24, 48 hours after admission
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto delle Scienze Neurologiche di Bologna
Study officials:
References:
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