Intracranial Pressure IncreaseONSDNCT06451289
Study on Optic Nerve Sheath Diameter Measurements in Prolonged Pediatric Seizures
An observational study of Intracranial Pressure Increase and Seizures, run by Balikesir University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Intracranial Pressure Increase, Seizures, Children, Only
- What is being tested?
- Head computered tomography
- How many people
- 197 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Balikesir Ataturk City Hospital
Balıkesir, Altieylul, 10100
About this study
Official title: 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).
Read the 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
- Being tested
- Head computered tomography
- Keywords
- Computed head tomography, Seizure, ONSD, elevated intracranial pressure
- Medical subject headings
- Intracranial Hypertension, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head computered tomographyDiagnostic test
Retrospective data collecting from medical records
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Head computered tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 4th to 5th hour of emergengy department admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Sep 2020
- Primary completion1 Dec 2021
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial Pressure IncreaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İpek Dokurel, Balikesir University
- Investigators
- İpek Dokurel Çetin, MD, Principal investigator, Balikesir Üniversity Medical faculty hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451289
- Sponsor's protocol ID
- ONSDseizureduration
- Acronym
- ONSD
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37247582
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Optic Nerve Sheath Diameter and Its Ratio to Eyeball Transverse Diameter Correlate With the Duration of Seizures in Post-ictal Children?
- ClinicalTrials.gov ID
- NCT06451289
- Acronym / sponsor ID
- ONSD / ONSDseizureduration
- Conditions
- Intracranial Pressure Increase, Seizures, Children, Only
- Keywords
- Computed head tomography, Seizure, ONSD, elevated intracranial pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postictal children | – | Diagnostic Test: Head computered tomographyPostictal 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. |
| the healthy controls | – | Diagnostic Test: Head computered tomographyPreviously healthy children admitted to the emergency department and having head CT without space-occupying/incidental lesions were determined as a control group. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head computered tomographyRetrospective data collecting from medical records | Diagnostic test | postictal children, the healthy controls |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Results publication: PubMed 37247582Handan 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İpek Dokurel Çetin, MD principal investigator
Balikesir Üniversity Medical faculty hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Pressure Increase and Seizures, run by Balikesir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
elevated ICP in postictal cildren (time frame: 0-4 hours of emergengy department admission). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06451289, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.