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Clinical Trials/NCT06057155
NCT06057155
Not yet recruiting
Not Applicable

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

IRCCS Istituto delle Scienze Neurologiche di Bologna1 site in 1 country150 target enrollmentMay 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intra Cerebral Hemorrhage
Sponsor
IRCCS Istituto delle Scienze Neurologiche di Bologna
Enrollment
150
Locations
1
Primary Endpoint
correlation between invasive ICP/ONSD
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2024
End Date
June 1, 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
IRCCS Istituto delle Scienze Neurologiche di Bologna
Responsible Party
Principal Investigator
Principal Investigator

Raffaele Aspide

Medical Doctor

IRCCS Istituto delle Scienze Neurologiche di Bologna

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

Outcomes

Primary Outcomes

correlation between invasive ICP/ONSD

Time Frame: 3, 24, 48 hours after admission

correlation between invasive intra-cranial pression assessment and ultasound ONSD assessment

Secondary Outcomes

  • correlation between invasive intra-cranial pression assessment and ultasound ratio of ONSD assessment and eyeball transverse diameter(3, 24, 48 hours after admission)

Study Sites (1)

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