| CTRI Number |
CTRI/2026/02/102947 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
28/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Optic Nerve Sheath Diameter as a Predictor of Raised Intracranial Pressure in ICU Patients With Intracranial Hemorrhage |
|
Scientific Title of Study
|
To Study Correlation Between Optic Nerve Sheath Diameter and CT Head Finding in Intracranial Bleed Patient as a Marker of Raised Intracranial Pressure in ICU Setting. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shikha Jain |
| Designation |
Resident Doctor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj
Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and
Research Centre, Waghodiya, Piparia ,Vadodara,GUJARAT,391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
7665516954 |
| Fax |
|
| Email |
shikharavijain27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Chauhan |
| Designation |
Professor |
| Affiliation |
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex,2nd Floor, Dhiraj
Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and
Research Centre,Waghodiya, Piparia,Vadodara,GUJARAT,391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9426368170 |
| Fax |
|
| Email |
dramitchauhan85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Chauhan |
| Designation |
Professor |
| Affiliation |
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex,2nd Floor, Dhiraj
Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and
Research Centre,Waghodiya, Piparia,Vadodara,GUJARAT,391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9426368170 |
| Fax |
|
| Email |
dramitchauhan85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Wagodhia , Pipariya,
Vadodara, Gujarat , India Pincode- 391760
|
|
|
Primary Sponsor
|
| Name |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Wagodhia , Pipariya,
Vadodara, Gujarat , India Pincode- 391760 |
| Type of Sponsor |
Private medical college |
|
|
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 Amit Chauhan |
Smt.Bhikiben Kanjibhai Shah Medical Institute |
Anaesthesia Department, General Ot Complex,
2nd Floor,
Dhiraj Hospital,
Smt.Bhikiben Kanjibhai Shah Medical Institute and
Research Centre, Waghodiya, Piparia ,Vadodara,GUJARAT,391760
India
Vadodara
GUJARAT |
9426368170
dramitchauhan85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1)Adult patients (18 years or older) admitted to the ICU with a diagnosis of intracranial hemorrhage confirmed by CT head imaging.
2)Patients who are hemodynamically stable and able to undergo ocular ultrasound examination.
3)Written informed consent obtained from patients or their legal representatives. |
|
| ExclusionCriteria |
| Details |
1.Patients with contraindications to ocular ultrasound examination (e.g., ocular trauma, globe rupture, or severe orbitopathy).
2. Patients with pre-existing optic nerve pathology or previous optic nerve surgery.
3.Patients with severe agitation or inability to cooperate with ocular ultrasound examination.
4.Patients who have undergone recent ocular surgery or trauma within the past month. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Validating ONSD as a reliable marker for elevated ICP could lead to its integration into clinical practice, enhancing the assessment and management of intracranial hemorrhage in ICU settings. |
Ocular ultrasound on admission to the icu.
After 24hrs .
After 48hrs.
After 72hrs.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Non-Invasive Monitoring: ONSD measurement offers a non-invasive alternative to traditional methods of ICP monitoring, reducing the need for invasive procedures and associated risks for critically ill patients. |
Ocular ultrasound on admission to the icu.
After 24hrs .
After 48hrs.
After 72hrs.
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
18/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/02/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
To study correlation between optic nerve sheath diameter and CT head finding in intracranial bleed patient as a marker of raised intracranial pressure in ICU settings: A prospective, observational study.
Objectives To determine the correlation between ONSD measurements obtained via ocular ultrasound and CT head findings indicative of raised ICP in ICU patients with intracranial hemorrhage.
To assess the feasibility and reliability of ONSD measurement as a non-invasive method for monitoring ICP in ICU settings.
Inclusion criteria Adult patients (18 years or older) admitted to the ICU with a diagnosis of intracranial hemorrhage confirmed by CT head imaging.
Patients who are hemodynamically stable and able to undergo ocular ultrasound examination.
Written informed consent obtained from patients or their legal representatives.
Exclusion criteria Patients with contraindications to ocular ultrasound examination (e.g., ocular trauma, globe rupture, or severe orbitopathy).
Patients with pre-existing optic nerve pathology or previous optic nerve surgery.
Patients with severe agitation or inability to cooperate with ocular ultrasound examination.
Patients who have undergone recent ocular surgery or trauma within the past month.
Site of Study: Department of Anesthesiology, Dhiraj Hospital, S.B.K.S. Medical Institute and Research Centre, Piparia, Waghodia, Vadodara
Study Design: Prospective, observational study.
Study Duration: The study will be initiated after obtaining permission from institutional ethics committee till the achievement of the sample size or by 12 months whichever is earlier.
Likely Outcome/benifit: Validating ONSD as a reliable marker for elevated ICP could lead to its integration into clinical practice, enhancing the assessment and management of intracranial hemorrhage in ICU settings.
|