Intracranial Pressure and Optic Nerve Sheath Diameter With CLOSED Bundle

Stroke, Ischemic Clinical Trial

— CLOSED  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06057155
• Other study ID #: 6669
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: March 2024
• Source: IRCCS Istituto delle Scienze Neurologiche di Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 1, 2026
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

-

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• ultrasound optic nerve sheath diameter assessment
ultrasound optic nerve sheath diameter assessment

Locations

Country	Name	City	State
Italy	IRCCS Istituto delle Scienze Neurologiche di Bologna	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Istituto delle Scienze Neurologiche di Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (15)

Aletreby W, Alharthy A, Brindley PG, Kutsogiannis DJ, Faqihi F, Alzayer W, Balhahmar A, Soliman I, Hamido H, Alqahtani SA, Karakitsos D, Blaivas M. Optic Nerve Sheath Diameter Ultrasound for Raised Intracranial Pressure: A Literature Review and Meta-analysis of its Diagnostic Accuracy. J Ultrasound Med. 2022 Mar;41(3):585-595. doi: 10.1002/jum.15732. Epub 2021 Apr 24. — View Citation

Aspide R, Bertolini G, Albini Riccioli L, Mazzatenta D, Palandri G, Biasucci DG. A Proposal for a New Protocol for Sonographic Assessment of the Optic Nerve Sheath Diameter: The CLOSED Protocol. Neurocrit Care. 2020 Feb;32(1):327-332. doi: 10.1007/s12028-019-00853-x. — View Citation

Aspide R, Bertolini G, Belotti LMB, Albini Riccioli L, Toni F, Mazzatenta D, Palandri G, Vetrugno L, Biasucci DG. Magnetic Resonance-Based Assessment of Optic Nerve Sheath Diameter: A Prospective Observational Cohort Study on Inter- and Intra-Rater Agreement. J Clin Med. 2023 Apr 5;12(7):2713. doi: 10.3390/jcm12072713. — View Citation

Aspide R, Bertolini G, Belotti LMB, Albini Riccioli L, Toni F, Mazzatenta D, Palandri G, Vetrugno L, Biasucci DG. The CLOSED protocol to assess optic nerve sheath diameter using color-Doppler: a comparison study in a cohort of idiopathic normal pressure hydrocephalus patients. Ultrasound J. 2022 Oct 29;14(1):43. doi: 10.1186/s13089-022-00291-5. — View Citation

Cardim D, Griesdale DE, Ainslie PN, Robba C, Calviello L, Czosnyka M, Smielewski P, Sekhon MS. A comparison of non-invasive versus invasive measures of intracranial pressure in hypoxic ischaemic brain injury after cardiac arrest. Resuscitation. 2019 Apr;137:221-228. doi: 10.1016/j.resuscitation.2019.01.002. Epub 2019 Jan 7. — View Citation

Cochrane Central Register of Controlled Trials - Optic nerve sheath diameter as a marker of raised intracranial pressure in pediatric patients with suspected ventriculoperitoneal shunt malfunction: a pilot study Ramirez T, Abdeen N Pediatric radiology. Conference: 60th annual meeting of the society for pediatric radiology, SPR 2017. Canada, 2017, 47, S255-S256 | added to CENTRAL: 30 June 2017 | 2017 Issue 6 https://doi.org/10.1007/s00247-017-3809-x

Hansen HC, Helmke K. Validation of the optic nerve sheath response to changing cerebrospinal fluid pressure: ultrasound findings during intrathecal infusion tests. J Neurosurg. 1997 Jul;87(1):34-40. doi: 10.3171/jns.1997.87.1.0034. — View Citation

Liu D, Kahn M. Measurement and relationship of subarachnoid pressure of the optic nerve to intracranial pressures in fresh cadavers. Am J Ophthalmol. 1993 Nov 15;116(5):548-56. doi: 10.1016/s0002-9394(14)73195-2. — View Citation

Montorfano L, Yu Q, Bordes SJ, Sivanushanthan S, Rosenthal RJ, Montorfano M. Mean value of B-mode optic nerve sheath diameter as an indicator of increased intracranial pressure: a systematic review and meta-analysis. Ultrasound J. 2021 Jul 2;13(1):35. doi: 10.1186/s13089-021-00235-5. — View Citation

Patterson DF, Ho ML, Leavitt JA, Smischney NJ, Hocker SE, Wijdicks EF, Hodge DO, Chen JJ. Comparison of Ocular Ultrasonography and Magnetic Resonance Imaging for Detection of Increased Intracranial Pressure. Front Neurol. 2018 Apr 24;9:278. doi: 10.3389/fneur.2018.00278. eCollection 2018. — View Citation

Robba C, Santori G, Czosnyka M, Corradi F, Bragazzi N, Padayachy L, Taccone FS, Citerio G. Optic nerve sheath diameter measured sonographically as non-invasive estimator of intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2018 Aug;44(8):1284-1294. doi: 10.1007/s00134-018-5305-7. Epub 2018 Jul 17. — View Citation

Toms DA. The mechanical index, ultrasound practices, and the ALARA principle. J Ultrasound Med. 2006 Apr;25(4):560-1; author reply 561-2. doi: 10.7863/jum.2006.25.4.560. No abstract available. — View Citation

Vaiman M, Abuita R, Bekerman I. Optic nerve sheath diameters in healthy adults measured by computer tomography. Int J Ophthalmol. 2015 Dec 18;8(6):1240-4. doi: 10.3980/j.issn.2222-3959.2015.06.30. eCollection 2015. — View Citation

Vitiello L, De Bernardo M, Rosa N. Optic Nerve Sheath Diameter Evaluation With Two Ultrasound Techniques in Patients at Risk for Increased Intracranial Pressure. Crit Care Med. 2019 Sep;47(9):e787. doi: 10.1097/CCM.0000000000003811. No abstract available. — View Citation

Zoerle T, Caccioppola A, D'Angelo E, Carbonara M, Conte G, Avignone S, Zanier ER, Birg T, Ortolano F, Triulzi F, Stocchetti N. Optic Nerve Sheath Diameter is not Related to Intracranial Pressure in Subarachnoid Hemorrhage Patients. Neurocrit Care. 2020 Oct;33(2):491-498. doi: 10.1007/s12028-020-00970-y. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation between invasive ICP/ONSD	correlation between invasive intra-cranial pression assessment and ultasound ONSD assessment	3, 24, 48 hours after admission
Secondary	correlation between invasive intra-cranial pression assessment and ultasound ratio of ONSD assessment and eyeball transverse diameter	correlation between invasive ICP/(ONSD/ETD)	3, 24, 48 hours after admission