| CTRI Number |
CTRI/2025/07/091504 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
comparative |
| Study Design |
Other |
|
Public Title of Study
|
A Non-Invasive Way to Watch Brain Pressure Changes During Surgery in children with Hydrocephalus |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amrita Rath |
| Designation |
Associate Professor |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of Anesthesiology
institute of medical Sciences
Banaras Hindu university
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7379140545 |
| Fax |
|
| Email |
amritar@bhu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
BABLI KUMARI |
| Designation |
Senior Resident |
| Affiliation |
Institute of medical sciences |
| Address |
Division of paediatric anaesthesia
Department of Anesthesiology
Institute of Medical Sciences, BHU
Division of paediatric anaesthesia
Department of Anesthesiology
Institute of Medical Sciences, BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
08709193564 |
| Fax |
|
| Email |
bbk.bhu08@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BABLI KUMARI |
| Designation |
Senior Resident |
| Affiliation |
Institute of medical sciences |
| Address |
Division of Paediatric anaesthesia
Department of anesthesiology
Institute of medical sciences, BHU
Division of Paediatric anaesthesia
Department of anesthesiology
Institute of medical sciences, BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
08709193564 |
| Fax |
|
| Email |
bbk.bhu08@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology |
| Address |
Institute of Medical Sciences, Banaras Hindu University |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| BABLI KUMARI |
Institute of Medical Sciences |
Division of pediatric anesthesia
Department of Anesthesiology
Institute of Medical Sciences, BHU
Varanasi
UTTAR PRADESH |
08709193564
bbk.babli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Banaras Hindu University Institute of Medical Scienecs, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G911||Obstructive hydrocephalus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
optic nerve sheath diameter (ONSD) using transorbital ultrasound |
measurement of ONSD using ultrasound before and after surgery that is MP-VP shunt and ETV |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
2.00 Year(s) |
| Gender |
Both |
| Details |
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)
|
|
| ExclusionCriteria |
| Details |
Age more than 2year
Patient’s attendants refusal
Associated with other systemic disease
Any intraoccular pathology
Anatomical distortion of orbit
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 |
ONSD measurement will be done before and after surgery to assess the dynamic change in the ONSD perioperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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
|