FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/077523 [Registered on: 02/12/2024] Trial Registered Prospectively
Last Modified On: 02/12/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   usefulness of eye ultrasound for brain injury patients 
Scientific Title of Study   BEDSIDE ULTRASONOGRAPHIC OPTIC NERVE SHEATH DIAMETER TO ASSESS INCREASED INTRA-CRANIAL PRESSURE: AN 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  SAURAV SHEKHAR 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  DEPARTMENT OF ANESTHESIOLOGY (TRAUMA & EMERGENCY) IGIMS PATNA

Patna
BIHAR
800014
India 
Phone  9308921568  
Fax    
Email  sauravshekhar99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  SAURAV SHEKHAR 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  DEPARTMENT OF ANESTHESIOLOGY (TRAUMA & EMERGENCY) IGIMS PATNA


BIHAR
800014
India 
Phone  9308921568  
Fax    
Email  sauravshekhar99@gmail.com  
 
Details of Contact Person
Public Query
 
Name  SAURAV SHEKHAR 
Designation  Associate Professor 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  DEPARTMENT OF ANESTHESIOLOGY (TRAUMA & EMERGENCY) IGIMS PATNA


BIHAR
800014
India 
Phone  9308921568  
Fax    
Email  sauravshekhar99@gmail.com  
 
Source of Monetary or Material Support  
Dept of Anesthesiology Trauma & Emergency Indira Gandhi Institute of Medical Sciences Patna Bihar 800001 Patna 
 
Primary Sponsor  
Name  DR SAURAV SHEKHAR 
Address  Department of Anesthesiology (Trauma & Emergency) IGIMS Patna 800014 Bihar PATNA 
Type of Sponsor  Other [self] 
 
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 Saurav Shekhar  Indira Gandhi Institute of Medical Sciences  DEPARTMENT OF ANESTHESIOLOGY (TRAUMA & EMERGENCY) IGIMS PATNA
Patna
BIHAR 
09308921568

sauravshekhar99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Indira Gandhi Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S062||Diffuse traumatic brain injury, (2) ICD-10 Condition: S064||Epidural hemorrhage, (3) ICD-10 Condition: S068||Other specified intracranial injuries, (4) ICD-10 Condition: S061||Traumatic cerebral edema, (5) ICD-10 Condition: S065||Traumatic subdural hemorrhage, (6) ICD-10 Condition: S069||Unspecified intracranial injury,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  all patients with traumatic brain injury having raised intracranial pressure such as ICH, STROKE and diffuse axonal injuries.  
 
ExclusionCriteria 
Details  patients with previous specific traumatic or structural ophthalmological pathology.
Age <18 years or >60 years,
eye or orbit diseases such as glaucoma, lens opacity or trauma 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) To correlate increase in optic nerve sheath diameter to raised intra-cranial pressure.  baseline
24hrs
48hrs 
 
Secondary Outcome  
Outcome  TimePoints 
to validate findings with gcs score  0, 24 hrs 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   15/12/2024 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

Point of care optic nerve sheath ultrasound (ONSUS) is a bedside practice that can be used to evaluate for increased intracranial pressure. Systematic review and meta-analysis have shown that ONSD of more than 5.00 to 5.70 mm has a concurrent ICP value above 20 mm Hg.

The use of point-of-care ultrasound (POCUS) has expanded considerably over the past two decades allowing for enhanced and swift evaluations, rapid triage, improved diagnostic capabilities in austere situations, and real-time assessment of focused clinical questions in critically ill patients in the intensive care unit (ICU). Emergency medicine physicians have led the way in establishing and educating bedside use of ultrasound. In 2001, the American College of Emergency Physicians (ACEP) published the first Emergency Ultrasound Guidelines to clarify the primary indications, the scope of practice, training, and continuing education regarding the use of emergency ultrasound.

The main complication associated with cerebral acute brain injury (ABI) is elevated intracranial pressure (ICP), as it is associated with high morbidity and mortality. Intracranial hypertension is defined as a sustained ICP greater than 20 mm Hg.  In these patients, multimodal neurological monitoring has positioned itself as a fundamental tool, both in emergency departments and in intensive care units (ICU), with a tendency, in recent years, to be minimally invasive. So much so that, in the care of these patients, the detection of increased ICP remains crucial, since it is associated with a worse prognosis. Thus, its early and timely diagnosis together with the implementation of adequate therapeutic measures are essential to ensure better patient outcomes. Ultrasound evaluation of the optic nerve sheath diameter (ONSD) has emerged in recent years as a useful non-invasive tool for estimating ICP or detecting intracranial hypertension. It is a safe technique that can be conducted at the bedside, in real time, and is reproducible, relatively low cost, and does not carry the risks of radiation.

OBJECTIVES:

1)     To correlate increase in optic nerve sheath diameter to raised intra-cranial pressure.

2)     To assess ONSD as predictor of unfavaourable outcome

 
Close