Study on Optic Nerve Sheath Diameter Measurements in Prolonged Pediatric Seizures

NCT06451289 | Completed

• 1 other identifier: ONSDseizureduration
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 88 postictal children with generalized or focal seizures were included in the study. The ONSD and ONSD/ETD ratio was measured independently by a pediatric neurologist and pediatric emergency expert, three times in both eyes using non-contrasted computed tomography taken within one hour after the seizure. The characteristics of seizures (duration, etiology, initiated treatment, and frequency) were recorded. Non-traumatic patients with normal head computed tomography findings at the hospital admission were considered as the control group (n=109).

Conditions

Intracranial Pressure Increase; Seizures; Children, Only

Keywords

Computed head tomography; Seizure; ONSD; elevated intracranial pressure

Outcome Measures

Primary Outcomes (3)

• elevated ICP in postictal cildren

  The investigators aim to show that elevated ICP which caused by prolonged seizures in children might be measured by optic nerve sheath diameter (ONSD) and ONSD/eyeball transverse diameter (ETD) ratios by head CT.

  0-4 hours of emergengy department admission

• to prove seizures cause elevated ICP by measuring optic nerve sheath diameter (ONSD) and optic nerve in sheath diameter to eyeball transverse diameter (ETD) ratio and comparing these results with healthy controls

  The investigators aim to prove that pediatric seizures cause elevated ICP. This could be predicted by measuring optic nerve sheath diameter (ONSD) and optic nerve sheath diameter to eyeball transverse diameter (ETD) ratio. And compare these measurements with healthy controls.

  4th to 5th hour of emergengy department admission

• to prove various seizure types cause variations in ICP and to show these can be detected by measuring optic nerve sheath diameter (ONSD) and optic nerve in sheath diameter to eyeball transverse diameter (ETD) ratio

  The investigators aim to detect the difference in ICP by measuring optic nerve sheath diameter (ONSD) and optic nerve sheath diameter to eyeball transverse diameter (ETD) ratio in children with focal and generalized seizures.And compare these results.

  4th to 5th hour of emergengy department admission

Study Arms (2)

postictal children

Postictal children aged one to 18 years who presented to the pediatric emergency department underwent head CT according to the Pediatric Emergency Care Applied Research Network (PECARN) guidelines. The seizures were observed by a health worker or directly with home videos.

Diagnostic Test: Head computered tomography

the healthy controls

Previously healthy children admitted to the emergency department and having head CT without space-occupying/incidental lesions were determined as a control group.

Diagnostic Test: Head computered tomography

Interventions

Head computered tomography DIAGNOSTIC_TEST

Retrospective data collecting from medical records

postictal children; the healthy controls

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Postictal children with generalized or focal seizures were admitted to the emergency department after seizures and were taken non-contrasted computed head tomography within one hour after the seizure.

You may qualify if:

• seizures were observed by a health worker or directly with home videos.
• prolonged seizures were used: those lasting more than 5 minutes for focal seizures and more than 10 minutes for generalized seizures.

You may not qualify if:

• Incomplete medical records; prior intracranial lesions, such as cysts (arachnoid, and pineal cysts),
• Chiari malformations, sequelae gliotic lesions, or incidental space-occupying lesions (cavernoma, lipoma, etc.);
• Chronic neuromuscular disease, metabolic or genetic disorders;
• Ocular trauma, periorbital cellulitis glaucoma, refraction errors, or optic disc drusen; or a history of retinopathy of prematurity
• Images with streak and movement artifacts, as well as images with pathologies that prevent measurement of the ONSD

Sponsors & Collaborators

• Balikesir University: lead

Study Sites (1)

Balikesir Ataturk City Hospital

Balıkesir, Altieylul, 10100, Turkey (Türkiye)

Location

Related Publications (1)

• Handan Gunsay R, Cikrikci Isik G, Yildirim M, Gokcek O, Korucu O, Cevik Y. Evaluation of postictal optic nerve sheath diameter at epileptic patients. Epilepsy Behav. 2023 Jul;144:109264. doi: 10.1016/j.yebeh.2023.109264. Epub 2023 May 27.

  PMID: 37247582 RESULT

MeSH Terms

Conditions

Intracranial Hypertension; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• İpek Dokurel Çetin, MD

  Balikesir Üniversity Medical faculty hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 11, 2024
• Study Start: September 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

TU (1)