| CTRI Number |
CTRI/2024/04/066013 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Optic nerve sheath diameter scan for monitoring increased pressure in intracranium |
|
Scientific Title of Study
|
Optic nerve sheath diameter as an indicator for intracranial pressure assessment and prediction |
| 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.MAHIMA L N |
| Designation |
Assistant professor, Department of anaesthesiology, MVJMC and RH |
| Affiliation |
MVJ Medical college and Research Hospital |
| Address |
Department of anaesthesiology, First floor, Ot complex, MVJMC and RH, Hoskote, Bangalore
Bangalore Rural
KARNATAKA
562114
India |
| Phone |
9108936169 |
| Fax |
|
| Email |
mahi.mahima30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MAHIMA L N |
| Designation |
Assistant professor, Department of anaesthesiology, MVJMC and RH |
| Affiliation |
MVJ Medical college and Research Hospital |
| Address |
Department of Anesthesiology, First floor, Ot complex, MVJMC and RH, Hoskote, Bangalore
KARNATAKA
562114
India |
| Phone |
9108936169 |
| Fax |
|
| Email |
mahi.mahima30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.MAHIMA L N |
| Designation |
Assistant professor, Department of anaesthesiology, MVJMC and RH |
| Affiliation |
MVJ Medical college and Research Hospital |
| Address |
Department of anaesthesiology, First floor, Ot complex, MVJMC and RH, Hoskote, Banglore
Bangalore Rural
KARNATAKA
562114
India |
| Phone |
9108936169 |
| Fax |
|
| Email |
mahi.mahima30@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology,Ot complex,MVJ Medical college and Research Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Mahima L N |
| Address |
Assistant professor, Department of Anaesthesiology, First floor, Ot complex, MVJMC and RH, Hoskte, Banglore,562114 |
| Type of Sponsor |
Other [Self] |
|
|
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 Mahima L N |
MVJ MEDICAL COLLEGE AND RESEARCH HOSPITAL |
Department of Anesthesiology, First floor,Ot complex,MVJ Medical college and Research Hospital, Hoskote, Bangalore 562114
Bangalore Rural
KARNATAKA |
09108936169
mahi.mahima30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MVJ MEDICAL COLLEGE AND RESEARCH HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G919||Hydrocephalus, unspecified, (2) ICD-10 Condition: G936||Cerebral edema, (3) ICD-10 Condition: G935||Compression of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with suspected raised ICP like stroke, liver failure, meningitis, meningoencephalitis, metabolic encephalopathy |
|
| ExclusionCriteria |
| Details |
Patients with a history of optic neuritis, arachnoid cyst of the optic nerve, high myopic, optic nerve trauma, and anterior orbital or cavernous sinus mass |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Because ONSD measurements are noninvasive, reusable, radiation-free, and applicable in a variety of contexts, they are a valuable tool for detecting elevated ICP at the bedside. Additional research is necessary to confirm its effectiveness in patients with elevated ICP. |
Patient after admitting in to ICU with 6 hrs interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Optic nerve sheet diameter vary from person to person |
Base line variables on time of admission of patient to ICU, Every 6 th hourly assessment done, Out come will be assessed every month. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2024 |
| Date of Study Completion (India) |
10/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
We will be conducting a prospective observational study. There will be dividing into two groups A and B. Group A will be, healthy controls and Group B - patients with possibility of elevated ICP. All these patients will be examining in the supine position using a 10 MHz phased linear array probe on the closed eyelids. The structures of the eye will be visualized to align the optic nerve directly opposite the probe, with the ONSD width perpendicular to the vertical axis of the scanning plane. A single ONSD will be measured 3.00 mm behind the globe in both the eyes. The ONSD measurements will be obtained averaging three readings from each eye to create a binocular ONSD measurement. In these controls a mean binocular ONSD will be measured and compared with group B. The the individual consent will be requested as the intervention is completely harmless, nonchargeable to the patient and no patient identification will be used. Security and confidentiality of data will be preserved and analyzed in aggregate.
|