| CTRI Number |
CTRI/2024/03/064836 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
21/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Correlation Of Optic Nerve Diameter with increased brain pressure |
|
Scientific Title of Study
|
Correlation Of Optic Nerve Sheath Diameter Measurement By Bedside Ultrasonography With Clinical And Radiologic Features Of Increased Intracranial Pressure. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AMOL GAJANAN ANDHALE |
| Designation |
SENIOR RESIDENT |
| Affiliation |
Department of Neurology AVBRH Sawangi meghe Wardha |
| Address |
Room no 101 block D Department of Neurology AVBRH Sawangi meghe Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
9834899112 |
| Fax |
|
| Email |
Amolmind007@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Tushar Patil |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of higher education and research centre |
| Address |
Room no 101 block D
Department of Neurology AVBRH Sawangi meghe Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
9021810293 |
| Fax |
|
| Email |
tushar.neuro@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Tushar Patil |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of higher education and research centre |
| Address |
DEPT. OF NEUROLOGY Jawaharlal Nehru Medical college, Sawangi Meghe, Wardha, Maharashtra
Wardha MAHARASHTRA 442001 India |
| Phone |
9021810293 |
| Fax |
|
| Email |
tushar.neuro@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Amol Andhale
MBBS MD Medicine
Senior resident department of Neurology block D
Jawaharlal Nehru Medical college, Sawangi Meghe, Wardha, Maharashtra |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of higher education and research centre |
| Address |
Department of Neurology AVBRH Sawangi meghe Wardha Block D Sawangi Meghe Wardha Near alphonsa school
Pin 442001 |
| 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 Amol Andhale |
Jawaharlal Neharu Medical College |
Room 101, Center of Neurosciences Block D, Acharya Ainoba Bhave rural hospital, Jawaharlal Nehru Medical College, Sawangi meghe wardha
442001 Wardha MAHARASHTRA |
9834899112
Amolmind007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of higher education |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G936||Cerebral edema, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Male |
| Details |
This is a single center observational prospective study conducted at the AVBRH hospital under the department of Neurology. All patients who admitted in neuro ICU were eligible for participation, subject to the inclusion and exclusion criteria.
Age more than18 years
Patients admitted to the Neuro ICU for neurological emergencies such as ischemic stroke, intracranial hemorrhage, traumatic brain injury, intracranial neoplasm, meningitis, encephalitis, hypoxic ischemic encephalopathy, CVST, PRES and cerebral edema of other etiology.
|
|
| ExclusionCriteria |
| Details |
1) Age less than 18
2) Significant ocular trauma
3) Active ocular infections
4) Mass lesions in the orbital area cavernous sinus, such as an arachnoid cyst
5) Proptosis due to any etiology
6) Known history of glaucoma.
7)Prior history of retinal detachment.
8) High myopia.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation of optic nerve sheath diameter by bedside USG with Features Of Increased Intracranial Pressure |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="260" Sample Size from India="260"
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)
|
01/04/2024 |
| 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 Yet Recruiting |
| 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
|
The study will be conducted in Neuro ICU of Acharya Vinoba Bhave rural Hospital (AVBRH), a tertiary care teaching hospital situated in the rural area of Wardha District. The aforementioned hospital, AVBRH, is a 1500+ bedded teaching hospital providing healthcare to the rural people of central India. Sampling Procedure: After approval from the Institutional Ethics Committee, a prospective, observational study will be conducted in Neuro ICU of Acharya Vinoba Bhave rural Hospital (AVBRH), a tertiary care teaching hospital situated in the rural area of Wardha District, Maharashtra, India. ONSD was measured in two group’s. These patients underwent ONSD measurement by an observer. An individual permission waiver will be acquired from the institute. Individuals with orbital fractures, hyperthyroidism, glaucoma, optic nerve tumours, neuritis, inflammatory eye edema, or external ophthalmic paresis have been not included. An ultrasound equipment equipped with a linear probe operating at 13–6 MHz with orbital imaging settings will be used to do ocular ultrasounds. An ICU physician with training in ONSD measurements conducted the measurements. The patients were lying down with their heads propped up 30 degrees. The closed eyelid will be covered with tegaderm, and the probe—which will be then positioned on the orbit’s superior and lateral surfaces—will be covered with a large amount of jelly. An electronic calliper will be used to measure ONSD in the two-dimensional mode, 3 mm behind the globe along an axis perpendicular to the optic nerve. An average of three readings have been taken for each eye. ONSD by ultrasound will be correlated with the CT/MRI findings of raised ICP reported by the radiologist. |