Optic Nerve Sonography to Monitor Intracranial Pressure After Ischemic sTrokE - The ONSITE Study

NCT06939114 | Completed

• 1 other identifier: 2018-01946
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the ONSITE study is to investigate whether an increase Optic nerve sheath diameter (ONSD) may help to predict intracranial hypertension (IH) after stroke. IH is a life-threatening complicaitons of malignant middle cerebral artery (MCA) infarction due to space-occupying brain edema. Patients at risk are monitored based on clinical symptoms, which can be difficult due to comorbidities such as delirium or systemic infections, which can hempen clinical judgement. Readily available, non-invasive methods to monitor ICP in stroke patients could help to earlier diagnose rising ICP and facilitate treatment decisions such as hemicraniectomy. This study investigates whether ONSD with optic nerve sonography (ONS) can detect brain edema after stroke.

Conditions

Malignant Media Infarction; Stroke; Intracranial Hypertension

Keywords

Stroke; Ischemic Stroke; Ultrasound; Optic nerve sheath; Optic nerve sheath diameter; Malignant media infarction; Intracranial pressure; Intracranial hypertension; Large vessel occlusion stroke

Outcome Measures

Primary Outcomes (1)

• Presence of intracranial hypertension

  Intracranial hypertension is defined in our study as midline shift ≥ 3mm or a decrease in GCS without any other cause based on clinical judgement or patient requiring hemicraniectomy.

  Assessed at Baseline, at 12 hours after stroke, at 24 hours after stroke, at 36 hours after stroke, at 48 hours after stroke, at 72 hours after stroke, at 120 hours after stroke.

Secondary Outcomes (3)

• National Institutes of Health Stroke Scale (NIHSS)

  Obtained at Baseline, at 12 hours after stroke, at 24 hours after stroke, at 36 hours after stroke, at 48 hours after stroke, at 72 hours after stroke, at 120 hours after stroke, at 3 months after stroke

• Glasgow Coma Scale (GCS)

  Obtained at Baseline, at 12 hours after stroke, at 24 hours after stroke, at 36 hours after stroke, at 48 hours after stroke, at 72 hours after stroke, at 120 hours after stroke, at 3 months after stroke

• modified Rankin Scale (mRS)

  mRS is measured 3 months after stroke

Study Arms (2)

Stroke

Patient with acute ischemic stroke

Non-Stroke, non-IH controls

Patient without acute stroke or history of intracranial hypertension

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

For non-stroke, non-IH patients we will recruit patients hospitalized at the Department of Neurology, University Hospital of Zurich. Patients within the clinic are screened for inclusion / exclusion criteria. If a patient is considered eligible for the study, he or she will be contacted by a member of the study team. For stroke patients acute stroke patients admitted to the Department of Neurology, University Hospital of Zurich will be screened for study eligibility. If a patient is considered eligible for the study, he or she will be contacted by a member of the study team after initial emergency care is completed.

You may qualify if:

• ≥ 18 years of age
• Consent according to the regulations of research in an emergency situation
• For non-Control patients: Acute ischemic stroke within 24 hours of recruitment

You may not qualify if:

• Known intracranial space-occupying lesion
• Known history of intracranial hypertension
• Contra-indications on ethical grounds
• Expected or known non-compliance to participate in the observational study, severe drug- or/and alcohol abuse

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (15)

• Bauerle J, Nedelmann M. Sonographic assessment of the optic nerve sheath in idiopathic intracranial hypertension. J Neurol. 2011 Nov;258(11):2014-9. doi: 10.1007/s00415-011-6059-0. Epub 2011 Apr 28.

  PMID: 21523461 BACKGROUND

• Bauerle J, Lochner P, Kaps M, Nedelmann M. Intra- and interobsever reliability of sonographic assessment of the optic nerve sheath diameter in healthy adults. J Neuroimaging. 2012 Jan;22(1):42-5. doi: 10.1111/j.1552-6569.2010.00546.x. Epub 2010 Dec 1.

  PMID: 21121998 BACKGROUND

• Toscano M, Spadetta G, Pulitano P, Rocco M, Di Piero V, Mecarelli O, Vicenzini E. Optic Nerve Sheath Diameter Ultrasound Evaluation in Intensive Care Unit: Possible Role and Clinical Aspects in Neurological Critical Patients' Daily Monitoring. Biomed Res Int. 2017;2017:1621428. doi: 10.1155/2017/1621428. Epub 2017 Mar 21.

  PMID: 28421189 BACKGROUND

• Tayal VS, Neulander M, Norton HJ, Foster T, Saunders T, Blaivas M. Emergency department sonographic measurement of optic nerve sheath diameter to detect findings of increased intracranial pressure in adult head injury patients. Ann Emerg Med. 2007 Apr;49(4):508-14. doi: 10.1016/j.annemergmed.2006.06.040. Epub 2006 Sep 25.

  PMID: 16997419 BACKGROUND

• Ohle R, McIsaac SM, Woo MY, Perry JJ. Sonography of the Optic Nerve Sheath Diameter for Detection of Raised Intracranial Pressure Compared to Computed Tomography: A Systematic Review and Meta-analysis. J Ultrasound Med. 2015 Jul;34(7):1285-94. doi: 10.7863/ultra.34.7.1285.

  PMID: 26112632 BACKGROUND

• Hansen HC, Helmke K. The subarachnoid space surrounding the optic nerves. An ultrasound study of the optic nerve sheath. Surg Radiol Anat. 1996;18(4):323-8. doi: 10.1007/BF01627611.

  PMID: 8983112 BACKGROUND

• 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

• Galetta S, Byrne SF, Smith JL. Echographic correlation of optic nerve sheath size and cerebrospinal fluid pressure. J Clin Neuroophthalmol. 1989 Jun;9(2):79-82.

  PMID: 2526162 BACKGROUND

• Dubourg J, Javouhey E, Geeraerts T, Messerer M, Kassai B. Ultrasonography of optic nerve sheath diameter for detection of raised intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2011 Jul;37(7):1059-68. doi: 10.1007/s00134-011-2224-2. Epub 2011 Apr 20.

  PMID: 21505900 BACKGROUND

• Ropper AH, Shafran B. Brain edema after stroke. Clinical syndrome and intracranial pressure. Arch Neurol. 1984 Jan;41(1):26-9. doi: 10.1001/archneur.1984.04050130032017.

  PMID: 6606414 BACKGROUND

• Schwab S, Aschoff A, Spranger M, Albert F, Hacke W. The value of intracranial pressure monitoring in acute hemispheric stroke. Neurology. 1996 Aug;47(2):393-8. doi: 10.1212/wnl.47.2.393.

  PMID: 8757010 BACKGROUND

• Wijdicks EF, Sheth KN, Carter BS, Greer DM, Kasner SE, Kimberly WT, Schwab S, Smith EE, Tamargo RJ, Wintermark M; American Heart Association Stroke Council. Recommendations for the management of cerebral and cerebellar infarction with swelling: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Apr;45(4):1222-38. doi: 10.1161/01.str.0000441965.15164.d6. Epub 2014 Jan 30.

  PMID: 24481970 BACKGROUND

• Heiss WD. Malignant MCA Infarction: Pathophysiology and Imaging for Early Diagnosis and Management Decisions. Cerebrovasc Dis. 2016;41(1-2):1-7. doi: 10.1159/000441627. Epub 2015 Nov 19.

  PMID: 26581023 BACKGROUND

• Hacke W, Schwab S, Horn M, Spranger M, De Georgia M, von Kummer R. 'Malignant' middle cerebral artery territory infarction: clinical course and prognostic signs. Arch Neurol. 1996 Apr;53(4):309-15. doi: 10.1001/archneur.1996.00550040037012.

  PMID: 8929152 BACKGROUND

• Hofmeijer J, Algra A, Kappelle LJ, van der Worp HB. Predictors of life-threatening brain edema in middle cerebral artery infarction. Cerebrovasc Dis. 2008;25(1-2):176-84. doi: 10.1159/000113736. Epub 2008 Jan 23.

  PMID: 18212524 BACKGROUND

MeSH Terms

Conditions

Stroke; Intracranial Hypertension; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 22, 2025
• Study Start: January 1, 2019
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: April 22, 2025

Record last verified: 2025-04

Locations

CH (1)