Intracranial Pressure and Optic Nerve Sheath Diameter With CLOSED Bundle

Not yet recruiting

• Conditions: Trauma, Brain; Subarachnoid Hemorrhage, Aneurysmal; Intra Cerebral Hemorrhage; Stroke, Ischemic; Hypertension Intracranial
• Interventions: Diagnostic Test: ultrasound optic nerve sheath diameter assessment

• Registration Number: NCT06057155
• Lead Sponsor: IRCCS Istituto delle Scienze Neurologiche di Bologna

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-21
• Study First Submitted QC: 2023-09-21
• Study First Posted: 2023-09-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Study Start: 2024-05-01
• Primary Completion: 2025-11-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
acute brain injury	ultrasound optic nerve sheath diameter assessment	Intra Cerebral Hemorrhage Subarachnoid Hemorrhage, Aneurysmal Trauma, Brain Stroke, Ischemic

Primary Outcome Measures

Name	Time	Method
correlation between invasive ICP/ONSD	3, 24, 48 hours after admission	correlation between invasive intra-cranial pression assessment and ultasound ONSD assessment

Secondary Outcome Measures

Name	Time	Method
correlation between invasive intra-cranial pression assessment and ultasound ratio of ONSD assessment and eyeball transverse diameter	3, 24, 48 hours after admission	correlation between invasive ICP/(ONSD/ETD)

Trial Locations

Locations (1)

IRCCS Istituto delle Scienze Neurologiche di Bologna; 🇮🇹 Bologna, Italy