| CTRI Number |
CTRI/2025/10/096479 [Registered on: 27/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Checking the eye nerve size before and after emergency brain surgery in head injury patients to understand brain pressures after head injury and how it changed during the course of surgery and its effects on recovery. |
|
Scientific Title of Study
|
Comparison of Perioperative Changes in Optic Nerve Sheath Diameter and their Impact on Neurological Outcomes in Patients Undergoing Decompressive Craniectomy for Traumatic Brain Injury – A Prospective 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 |
Dr Prasanna Udupi Bidkar |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Room no 2,Department of Anaesthesiology and Critical Care,2nd floor Hospital block,Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9442706168 |
| Fax |
|
| Email |
drprasannabidkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasanna Udupi Bidkar |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Room no 2,Department of Anaesthesiology and Critical Care,2nd floor Hospital block,Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9442706168 |
| Fax |
|
| Email |
drprasannabidkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parismita Baruah |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Room no 3,Department of Anaesthesiology and Critical Care,2nd floor Hospital block,Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9577303046 |
| Fax |
|
| Email |
baruahparismita99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research,Pondicherry, pincode- 605006,India. |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
room number 2, Department of Anaesthesiology and critical care, Jawaharlal Institute of Postgraduate Medical Education and Research,Pondicherry, pincode-605006,India |
| 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 |
| Dr Parismita Baruah |
Jawaharlal Institute of Postgraduate Medical Education Research , Pondicherry |
Room no 2, 2nd floor hospital block, Department of Anaesthesiology and Critical Care,Jawaharlal Institute of Postgraduate Medical Education Research , Pondicherry, pincode-605006, India
Pondicherry
PONDICHERRY |
9577303046
baruahparismita99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Observational Studies Jawaharlal Institute of Postgraduate Medical Education |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S062||Diffuse traumatic brain injury, (2) ICD-10 Condition: S065||Traumatic subdural hemorrhage, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 18 to 65 years
Isolated traumatic brain injury |
|
| ExclusionCriteria |
| Details |
Patients with orbital injury.Preoperative disorders such as neoplasms, inflammatory disorders of eye, graves disease, and extrinsic compression of optic nerve will be excluded. Patients undergoing bifrontal decompressive craniectomy. Polytrauma. Pregnant patients. Hemodynamic instability.Refusal to consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the degree of changes in optic nerve sheath diameter perioperatively in patients undergoing decompressive craniectomy for traumatic brain injury. |
Immediate preoperative,end operative, post operative 6hours, 12 hours, and 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate correlation between perioperative optic nerve sheath diameter and neurological outcomes of traumatic brain injury.
To evaluate the perioperative change in optic nerve sheath diameter based on laterality of injury/side of Decompressive craniectomy.
To evaluate the correlation between preoperative optic nerve sheath diameter(non invasive) and intraoperative invasive intracranial pressure ( icp) |
At postoperative 3 months |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
07/11/2025 |
| 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="1"
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
|
This study is about checking the size of optic nerve sheath diameter which is considered an indirect and almost accurate measurement of intracranial pressure before and after emergency decompressive craniectomy for traumatic brain injury patients. As we know traumatic brain injury is a global health burden and the deleterious effects of traumatic brain injury is due to raised intracranial pressure and decompressive craniectomy is a third tier and highest level of treatment of raised intracranial pressure. The perioperative trend of intracranial pressure and it’s supposedly return to normalcy by using non invasive techniques like optic nerve sheath diameter which is a bedside tool and be used to see how it affect the neurological outcomes in those patients. Expecting significant reduction in optic nerve sheath diameter values post decompressive craniectomy implies a reduction in intracranial pressure and hence should be associated with a better neurological outcome. |