FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/04/024567 [Registered on: 13/04/2020] Trial Registered Prospectively
Last Modified On: 04/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Utrasound of the eye to detect raised intracranial pressure 
Scientific Title of Study   Assessment of optic nerve sheath diameter measured by bedside sonography as a predictor of raised intracranial pressure in adults. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Apoorv Jain 
Designation  Senior Resident 
Affiliation  Fortis Memorial Research Institute 
Address  Department of critical care medicine, Fortis Memorial Research Institute Sector-44

Gurgaon
HARYANA
122001
India 
Phone    
Fax    
Email  apoorvjain16@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep Dewan 
Designation  Director 
Affiliation  Fortis Memorial Research Institute 
Address  Department of critical care medicine, Fortis Memorial Research Institute, Sector-44

Gurgaon
HARYANA
122001
India 
Phone    
Fax    
Email  sandeepdewan28@gmail.com  
 
Details of Contact Person
Public Query  
Name  Apoorv Jain 
Designation  Senior Resident 
Affiliation  Fortis Memorial Research Institute 
Address  Department of Critical Care Medicine, Fortis Memorial Research Institute Sector-44

Gurgaon
HARYANA
122001
India 
Phone    
Fax    
Email  apoorvjain16@gmail.com  
 
Source of Monetary or Material Support  
none 
 
Primary Sponsor  
Name  Fortis Memorial Research institute 
Address  Sector-44, Gurugram, Haryana 
Type of Sponsor  Research institution and hospital 
 
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 Apoorv Jain  Fortis Memorial Research Institute  Department of Critical Care Medicine Sector 44
Gurgaon
HARYANA 		 9999653544

apoorvjain16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G939||Disorder of brain, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Age > 18 years
2.Patient with clinical features of raised ICP such as headache, vomiting, blurring of vision, altered sensorium, GCS<13.
3.Moderate to severe traumatic brain injury (Glasgow coma scale <13)
4.Progressive neurological deterioration since admission
5.History of active malignancy with new onset confusion
 
 
ExclusionCriteria 
Details  1. Age <18 years
2. Orbital trauma
3. Orbital mass
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the correlation of optic nerve sheath diameter measured by bedside ultrasonography and the features of raised intracranial pressure on neuroimaging.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the normal optic nerve sheath diameter by bedside ultrasonography in the Indian population.  2 years 
To determine optimal cut off point of optic nerve sheath diameter to detect raised intracranial pressure  2 years 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   16/04/2020 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
  1. Various studies have investigated Optic nerve sheath diameter (ONSD) as a marker for elevated intracranial pressure (ICP) and have found good correlation between the two. Further, ONSD diameter as measured by bedside ultrasonography, has been found to be well correlated with that measured with the help of MRI images.
  2. To the best of our knowledge, there is paucity of Indian studies which show correlation between the ONSD values as measured by ultrasonography and the signs of raised ICP on neuroimaging modalities (CT/MRI scans).

AIMS & OBJECTIVES

  1. To determine the normal optic nerve sheath diameter measured by bedside ultrasonography in the Indian population
  2. To study the correlation of optic nerve sheath diameter measured by bedside ultrasonography and the features of raised intracranial pressure on neuroimaging.
  3. To determine optimal cut off point of optic nerve sheath diameter to detect raised intracranial pressure
METHODOLOGY
Linear ultrasound probe will be used to measure the ONSD as the outer limits of the 2 hyperechoic lines, using electronic callipers, 3mm behind the papilla.
ONSD cut-off of 5mm will be used to define the presence of intracranial hypertension.

Patients with any one of the following findings on neuroimaging will be considered to have raised intracranial pressure-

  1. Midline shift > 3mm
  2. Sulcal effacement with significant oedema
  3. Compression of third ventricle
  4. Hydrocephalus

 
Close