Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451289
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2024-06-03
Brief Title:
Study on Optic Nerve Sheath Diameter Measurements in Prolonged Pediatric Seizures
Sponsor:
Balikesir University
Organization:
Balikesir University
Study Overview
Official Title:
Does Optic Nerve Sheath Diameter and Its Ratio to Eyeball Transverse Diameter Correlate With the Duration of Seizures in Post-ictal Children
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ONSD
Brief Summary:
A total of 88 postictal children with generalized or focal seizures were included in the study
The ONSD and ONSDETD 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 n109
The ONSD and ONSDETD 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 n109
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-occupyingincidental lesions were determined as a control group
The participants were divided into two groups postictal children n88 and healthy controls n109 Furthermore the postictal children were divided into two groups namely those with focal n56 and generalized n32 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 ONSDETD 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
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-occupyingincidental lesions were determined as a control group
The participants were divided into two groups postictal children n88 and healthy controls n109 Furthermore the postictal children were divided into two groups namely those with focal n56 and generalized n32 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 ONSDETD 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None