| CTRI Number |
CTRI/2025/10/095559 [Registered on: 01/10/2025] Trial Registered Prospectively |
| Last Modified On: |
01/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparing ultrasound and CT Scan of the eye nerve to detect high brain pressure in stroke patients |
|
Scientific Title of Study
|
A comparative evaluation of optic nerve sheath diameter via ultrasonography and CT imaging as a predictor of raised intracranial pressure in suspected stroke patients- 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 Akshay Ramesh Cheke |
| Designation |
Junior Resident Doctor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe Institute of Higher Education and Research, (Deemed to be University), Sawangi (Meghe), Wardha- 442107 Maharashtra
Wardha
MAHARASHTRA
442107
India |
| Phone |
7798610315 |
| Fax |
|
| Email |
akshaycheke15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditya Pundkar |
| Designation |
Professor and Head Department of Emergency Medicine |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe Institute of Higher Education and Research, (Deemed to be University), Sawangi (Meghe), Wardha- 442107 Maharashtra
Wardha
MAHARASHTRA
442107
India |
| Phone |
9975170898 |
| Fax |
|
| Email |
draditya.pundkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshay Ramesh Cheke |
| Designation |
Junior Resident Doctor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe Institute of Higher Education and Research, (Deemed to be University), Sawangi (Meghe), Wardha- 442107 Maharashtra
Wardha
MAHARASHTRA
442107
India |
| Phone |
7798610315 |
| Fax |
|
| Email |
akshaycheke15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education & Research |
|
|
Primary Sponsor
|
| Name |
Dr Akshay Ramesh Cheke |
| Address |
Room no. S2, Raghobaji PG boys hostel, Datta Meghe institute of Higher Education and Research(Deemed to be university) Sawangi(Meghe), Wardha-442107 Maharashtra |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Datta Meghe institute of Higher Education |
Datta Meghe institute of Higher Education and Research(Deemed to be university) Sawangi(Meghe), Wardha-442107 Maharashtra |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akshay Ramesh Cheke |
Acharya Vinobha Bhave Rural Hospital. |
Deparment of Emergency Medicine ,Jawaharlal Nehru Medical College and Acharya Vinobha Bhave Rural Hospital.
Datta Meghe institute of Higher Education and Research(Deemed to be university) Sawangi(Meghe), Wardha-442107 Maharashtra
Wardha
MAHARASHTRA |
7798610315
akshaycheke15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I679||Cerebrovascular disease, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patient age more than 18 year presenting to emergency department with suspected stroke |
|
| ExclusionCriteria |
| Details |
1 Patients with any history of ophthalmic pathology/ manifestation
2 Post cardiac arrest patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate optic nerve sheath diameter using ultrasonography in patient with suspected stroke in comparison with CT scan to predict raised intracranial pressure.
|
20 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To asses correlation between optic nerve sheath diameter measurement and GCS to predict raised intracranial pressure. |
10 mins |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
01/11/2025 |
| 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
|
Primary Purpose of the Protocol The primary purpose of this study is to evaluate and compare the accuracy of optic nerve sheath diameter (ONSD) measurement using bedside ultrasonography versus CT imaging as predictors of raised intracranial pressure (ICP) in suspected stroke patients presenting to the emergency department.
Study Hypothesis We hypothesize that ultrasonographic measurement of ONSD is comparable to CT imaging in detecting raised intracranial pressure, and that bedside ultrasound may serve as a reliable, rapid, and non-invasive alternative for early diagnosis in suspected stroke patients. |