Intracranial Pressure and Optic Nerve Sheath Diameter With CLOSED Bundle

NCT06057155 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 6669
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• correlation between invasive ICP/ONSD

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

  3, 24, 48 hours after admission

Secondary Outcomes (1)

• correlation between invasive intra-cranial pression assessment and ultasound ratio of ONSD assessment and eyeball transverse diameter

  3, 24, 48 hours after admission

Study Arms (1)

acute brain injury

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

Diagnostic Test: ultrasound optic nerve sheath diameter assessment

Interventions

ultrasound optic nerve sheath diameter assessment DIAGNOSTIC_TEST

ultrasound optic nerve sheath diameter assessment

acute brain injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

acute brain injury patients at risk of intra-cranial hypertension

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Istituto delle Scienze Neurologiche di Bologna: lead

Study Sites (1)

IRCCS Istituto delle Scienze Neurologiche di Bologna

Bologna, Italy

Location

Related Publications (15)

• 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.

  PMID: 9202262 BACKGROUND

• 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.

  PMID: 8238213 BACKGROUND

• 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.

  PMID: 32314244 BACKGROUND

• 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.

  PMID: 31415320 BACKGROUND

• 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.

  PMID: 26682181 BACKGROUND

• 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.

  PMID: 29740393 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 30019201 BACKGROUND

• 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.

  PMID: 34215966 BACKGROUND

• 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.

  PMID: 33893746 BACKGROUND

• 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.

  PMID: 30629992 BACKGROUND

• 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.

  PMID: 31583527 BACKGROUND

• 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.

  PMID: 36309606 BACKGROUND

• 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.

  PMID: 37048796 BACKGROUND

• 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.

  PMID: 16567451 BACKGROUND

MeSH Terms

Conditions

Cerebral Hemorrhage; Subarachnoid Hemorrhage; Brain Injuries, Traumatic; Intracranial Hypertension; Ischemic Stroke

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stroke

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: May 1, 2024
• Primary Completion: November 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)