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CTRI Number  CTRI/2024/03/063603 [Registered on: 05/03/2024] Trial Registered Prospectively
Last Modified On: 21/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   To observe the diameter of nerve sheath of the nerve from the eyeball in relation to the pressure inside the brain 
Scientific Title of Study   Correlation of Optic Nerve Sheath Diameter with External Ventricular Drain for measurement of Intracranial Pressure : An Observational Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ismail Shahidullah 
Designation  Post Doctoral Trainee 
Affiliation  Institute of Neurosciences, Kolkata 
Address  Department of Neuroanaesthesia and Critical Care, Institute of Neurosciences, Kolkata 185/1 A.J.C. Bose Road, Kolkata 700 017
Institute of Neurosciences, Kolkata 185/1 A.J.C. Bose Road, Kolkata 700 017
Kolkata
WEST BENGAL
700017
India 
Phone  9051558708  
Fax    
Email  discover.5660@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Bibhukalyani Das 
Designation  Professor 
Affiliation  Institute of Neurosciences, Kolkata 
Address  Department of Neuroanaesthesia and Critical Care, Institute of Neurosciences, Kolkata 185/1 A.J.C. Bose Road, Kolkata 700 017
Institute of Neurosciences, Kolkata 185/1 A.J.C. Bose Road, Kolkata 700 017
Kolkata
WEST BENGAL
700017
India 
Phone  9836000519  
Fax    
Email  bibhukalyanidas@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ismail Shahidullah 
Designation  Post Doctoral Trainee 
Affiliation  Institute of Neurosciences, Kolkata 
Address  Department of Neuroanaesthesia and Critical Care, Institute of Neurosciences, Kolkata 185/1 A.J.C. Bose Road, Kolkata 700 017
Institute of Neurosciences, Kolkata 185/1 A.J.C. Bose Road, Kolkata 700 017
Kolkata
WEST BENGAL
700017
India 
Phone  9051558708  
Fax    
Email  discover.5660@gmail.com  
 
Source of Monetary or Material Support  
Institute of Neurosciences, Kolkata 185/1 A.J.C. Bose Road, Kolkata-700017  
 
Primary Sponsor  
Name  Institute of Neurosciences Kolkata 
Address  185/1 A.J.C. Bose Road, Kolkata 700 017, West Bengal 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ismail Shahidullah  Institute of Neurosciences, Kolkata  Department of Neuroanaesthetia and critical care,Operation theatre and Intensive Therapy Unit,185/1 A.J.C. Bose Road, Kolkata 700 017
Kolkata
WEST BENGAL 
9051558708

discover.5660@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, Institute of Neurosciences kolkata  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G919||Hydrocephalus, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Adult patients (aged ≥18 years)
2. Either Gender
3. Isolated Brain injury
4. Patients requiring EVD 
 
ExclusionCriteria 
Details  1. Adult patients (aged ≥18 years)
2. Either Gender
3. Isolated Brain injury
4. Patients requiring EVD 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Optic nerve sheath diameter(ONSD)   At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Decompressive craniectomy  At 5 mins from 0 hours 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   10/03/2024 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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   After getting institutional ethics committee  approval, CTRI no. and written consent of
patient’s nearest of kin, patients will be included in this study.The demographic data (age ,gender,
race),Glasgow Coma Score(GCS),pupillary size and reactions, vital signs(heart rate ,respiratory
rate,blood pressure,temperature) and CT scan findings will be recorded on admission to ITU. The
verbal score of GCS will be modified for intubated patients using the formula: Derived Verbal
Score=−0.3756+Motor Score×(0.5713)+Eye Score×(0.4233)[17].All patients will be sedated with
midazolam and fentanyl administered intravenously, according to the treating physician’s
discretion. Following the decision to place an ICP monitoring device (EVD) (by the attending
intensive care physician and neurosurgeon), the patients will be enrolled in this study.Ocular US
will be conducted with SonoSite Micromax (SonoSite Inc., Bothell, WA, USA) ultrasonography
(USG) machine. Each patient will be examined in the supine position using a linear USG probe of
10-5 MHz frequency to get ONSD at 3 mm posterior to the ocular globe. The probe will be applied
on the temporal part of the closed upper eyelid with coupling gel [18] [19]. For each patient,
investigator will perform two measurements on each eye in transverse plane. The resulting four
measurements will then be averaged to yield a mean ONSD to minimise intraobserver variability.
Initial US ONSD will be measured before placement of the EVD catheter. The opening pressure
after placement of the EVD catheter, will be used as the initial ICP, and Intracranial hypertension
will be considered present when the patient will be having ICP above 20 mmHg for a period of
time greater than 5 min.The investigator measuring the ONSD with ultrasonography will be
blinded to invasive measurements of ICP. The need for urgent life saving surgery i.e.
Decompressive Craniectomy will also be noted.
 
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