| CTRI Number |
CTRI/2026/04/108226 [Registered on: 13/04/2026] Trial Registered Prospectively |
| Last Modified On: |
13/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Initial Screening Tools in Severe Traumatic Brain Injury |
|
Scientific Title of Study
|
Utility of automated infrared pupillometry and Optic Nerve Sheath Diameter and as Initial Screening Tools in Severe Traumatic Brain Injury |
| 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 Anand Tiwari |
| Designation |
Senior NTU Consultant |
| Affiliation |
Grant Medical Foundation Ruby Hall Clinic |
| Address |
40 Sassoon Road Pune 411001
Pune
MAHARASHTRA
411001
India |
| Phone |
7798255626 |
| Fax |
|
| Email |
dranandtiwari@rubyhall.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrinidhi Sunilkumar Deshpande |
| Designation |
Drnb CCM student |
| Affiliation |
Grant Medical Foundation, Ruby Hall Clinic |
| Address |
40 Sassoon Road Pune 411001
Pune
MAHARASHTRA
411001
India |
| Phone |
8861425977 |
| Fax |
|
| Email |
shrinidhisd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shrinidhi Sunilkumar Deshpande |
| Designation |
Drnb CCM student |
| Affiliation |
Grant Medical Foundation, Ruby Hall Clinic |
| Address |
40 Sassoon Road Pune 411001
Pune
MAHARASHTRA
411001
India |
| Phone |
8861425977 |
| Fax |
|
| Email |
shrinidhisd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Grant Medical Foundation Ruby Hall Clinic 40 Sassoon Road Pune 411001 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Grant Medical Foundation Ruby Hall Clinic |
| Address |
40 Sassoon Road Pune 411001 |
| Type of Sponsor |
Other [Trust 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 Shrinidhi Sunilkumar Deshpande |
Grant Medical Foundation Ruby Hall Clinic |
Grant medical foundation ruby hall clinic main building 2nd floor Neuro trauma department 40 Sassoon Road Pune 411001
Pune
MAHARASHTRA |
8861425977
02066455628
shrinidhisd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Poona Medical Research Foundation Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S062||Diffuse traumatic brain injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Severe head trauma
2 Prehospital GCS less than 9
3 Intracranial lesion identified on initial CT head |
|
| ExclusionCriteria |
| Details |
1 Penetrating Head Injury
2 Bilateral ocular trauma or eyelid injury precluding pupillometry or ONSD
3 Prior enrolment in the study
4 Pre existing ocular disease significantly distorting ONSD or pupillary anatomy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
ICU stay duration
In-hospital mortality
Neurosurgical Intervention |
72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
23/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/04/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="10"
Days="4" |
|
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
|
- Clinical need - Decisions to escalate beyond Seattle International Severe Traumatic Brain Injury Consensus Conference SIBICC tier-0 carry major implications sedation hyperosmolar therapy ICP monitoring and decompressive surgery. As a screening tool at admission can prioritize monitoring beds and early interventions - ORANGE study establishes NPi as a dynamic outcome predictor in acute brain injury—justifying NPi as admission screen [4] - Ultrasound ONSD not only is a non-invasive and easy to do, quick procedure but also improves feasibility - To date no study has rigorously evaluated NPi + ONSD at admission to predict INCC (rather than ICP alone or long-term outcome). Demonstrating that NPi less than 3 and or ONSD abnormal yields a low negative likelihood ratio for requirement for intensive neurocritical care would provide a practical, non-invasive rule-out bundle for early triage. - Both AIP and ONSD can be completed within minutes of ICU arrival, prior to osmotherapy or deep sedation, enabling early classification and potential protocolization across centres with varied neuromonitoring capacity. |