Study on Optic Nerve Sheath Diameter Measurements in Prolonged Pediatric Seizures

NCT ID: NCT06451289

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 197 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-12-01

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).

Detailed Description

This was a prospective observational case-control study. The study included children aged 1 to 18 years who had undergone cranial CT scans in accordance with the Pediatric Emergency Care Applied Research Network (PECARN) guidelines between September 2020 and December 2022.

The seizures only observed by a health worker or directly with home videos were taken into consideration.

The definition of prolonged seizures proposed by the ILAE Task Force on Classification of Status Epilepticus was employed: those lasting more than five minutes for focal seizures and more than ten minutes for generalized seizures.

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

The participants were divided into two groups: postictal children (n=88) and healthy controls (n=109). Furthermore, the postictal children were divided into two groups, namely those with focal (n=56) and generalized (n=32) seizures.

The following variables were recorded from the medical records: patients' demographic characteristics (age, sex, body mass index), type of seizures (focal or generalized), the duration of seizures, seizure frequency, type of medication initiated, and the etiology of the seizures.

To ensure the highest standards of care, the pediatric head CTs were independently reviewed by a pediatric neurologist and a pediatric emergency expert.

The investigators measured Optic Nerve Sheath Diameter as a thickness at a distance of 3 mm from the optic disc.

The investigators measured the Eyeball Transverse Diameter via axial images, using the widest diameter of each eyeball from retina to retina.

The data were presented in the form of frequencies and percentiles for categorical variables and means with standard deviations (SDs) or medians with interquartile ranges for continuous variables.

The Mann-Whitney U tests were employed to ascertain the significance of the differences in ONSD and ONSD/ETD ratio observed between the independent groups.

A receiver operating curve (ROC) was constructed and the area under the curve (AUC) was measured in order to evaluate the discrimination ability.

Conditions

Intracranial Pressure Increase; Seizures; Children, Only

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Head computered tomography

Intervention Type: DIAGNOSTIC_TEST

Retrospective data collecting from medical records

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.

Head computered tomography

Intervention Type: DIAGNOSTIC_TEST

Retrospective data collecting from medical records

Interventions

Head computered tomography

Retrospective data collecting from medical records

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Balikesir University

OTHER

Sponsor Role: lead

Responsible Party

İpek Dokurel

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

İpek Dokurel Çetin, MD

Role: PRINCIPAL_INVESTIGATOR

Balikesir Üniversity Medical faculty hospital

Locations

Balikesir Ataturk City Hospital

Balıkesir, Altieylul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 37247582 (View on PubMed)

Other Identifiers

ONSDseizureduration

Identifier Type: -

Identifier Source: org_study_id