Study on Optic Nerve Sheath Diameter Measurements in Prolonged Pediatric Seizures (ONSD)

June 7, 2024 updated by: İpek Dokurel, Balikesir University

Does Optic Nerve Sheath Diameter and Its Ratio to Eyeball Transverse Diameter Correlate With the Duration of Seizures in Post-ictal Children?

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
197

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Altieylul
      • Balikesir, Altieylul, Turkey, 10100
        • Balikesir Ataturk City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
Diagnostic test: Head computered tomography
Retrospective data collecting from medical records

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
elevated ICP in postictal cildren
Time Frame: 0-4 hours of emergengy department admission
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
Time Frame: 4th to 5th hour of emergengy department admission
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
Time Frame: 4th to 5th hour of emergengy department admission
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Balikesir University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: İpek Dokurel Çetin, MD, Balikesir Üniversity Medical faculty hospital

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ONSDseizureduration

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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