FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
Close