跳至主要内容
临床试验/CTRI/2025/07/091504
CTRI/2025/07/091504尚未招募不适用

Dynamicity of the optic nerve sheath diameter using transorbital ultrasonography perioperatively in pediatric patients diagnosed with hydrocephalus undergoing either endoscopic third ventriculostomy or medium pressure ventriculoperitoneal shunt

Department of Anesthesiology1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
a) To assess the dynamic variability in transorbital ultrasonographic ONSD in pediatric patients diagnosed with hydrocephalus before and after undergoing medium pressure VPshunt (MPVP shunt) and ETV procedure

研究概览

简要总结

Hydrocephalus is an accentuated accumulation of cerebrospinal fluid (CSF) volume within the ventricles and cisterns, leading to ventriculomegaly within the brain parenchyma. It occurs due to an imbalance between production or absorption in CSF. . The overall incidence of hydrocephalus in children in the developed countries is approximately 1 in 1000 live birthswhereas, in developing countries like India it is, 0.2 to 0.5 in 1000 live births. There are different modalities to diagnose the hydrocephalus, i.e, clinically and also radiologically, like computed tomography (CT) brain and Magnetic resonance imaging (MRI)brain. Measuring the increase in the ICP by using an invasive intraventricular catheter is not possible in neonates and children as they do not cooperate post-operatively and need sedation or general anesthesia to do so. The optic nerve sheath is a perineural compartment around the optic nerve that communicates with the subarachnoid space. Thus, nowadays, optic nerve sheath diameter (ONSD) is used as a bedside transorbital ultrasonography for assessing the raised intracranial pressure by measuring the intraorbital part of the optic nerve sheath and it is easy, safe, non-invasive tool for the early estimation of an increase in intracranial pressure. A ventriculoperitoneal shunt (V-P shunt) and Endoscopic third ventriculostomy (ETV) are two different procedures that are performed to treat the hydrocephalus and decrease the ICP. we estimate the decrease in ICP by measuring the change in the transorbital ultrasonography for ONSD preoperatively and after V-P shunt or ETV. This study aims to measure the change in the ONSD in pediatric patients with hydrocephalus before and after intervention perioperatively and also to assess the total duration needed to extubate patient postoperatively, post ONSD assessment

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 2.00 Year(s)(—)
性别
All

入选标准

  • Pediatric patients, including neonates and infants till 2 years of age diagnosed with hydrocephalus with raised ICP posted for either MPVP shunt or ETV.
  • Either sex (Male/Female).

排除标准

  • Age more than 2year Patient’s attendants refusal Associated with other systemic disease Any intraoccular pathology Anatomical distortion of orbit.

结局指标

主要结局

a) To assess the dynamic variability in transorbital ultrasonographic ONSD in pediatric patients diagnosed with hydrocephalus before and after undergoing medium pressure VPshunt (MPVP shunt) and ETV procedure

时间窗: ONSD measurement will be done before and after surgery to assess the dynamic change in the ONSD perioperatively

次要结局

  • a) To estimate the change in vitals such as systolic blood pressure, mean arterial pressure, heart rate, end tidal Carbon dioxide (EtCO2) preoperatively, at the time of intervention, after intervention and before extubation.(this measurement will be done after intubation, before intervention, at the time of intervention and before extubation of the patient)
  • Time of measurement of ONSD after insertion of equipment in the ventricular system(This measuremnt will be taken just at the time of insertion of instrument to the ventricular system till the assessment of ONSD before extubation)
  • To assess the need for ventilatory support postoperatively.(post operative assessment of ventilatory requirement)
  • Number of ventilator days in ICU(Post opertaive number of ventilator days required by patient)
  • Total duration of hospital stays(post operative number of days stayed in hospital)
  • Any post operative complication post operative in hospital stay(post operative complication post operative in hospital stay like seizure, vomiting, intubation, shunt failure etc)
  • time to extubate the patient after ONSD assessment(after postoperative assessment of ONSD, total time required to extubate the patient)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Amrita Rath

Institute of Medical Sciences

研究点 (1)

Loading locations...

相似试验