| 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
|
|
|
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
|
|
|
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. |