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CTRI Number  CTRI/2025/08/093087 [Registered on: 14/08/2025] Trial Registered Prospectively
Last Modified On: 14/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study on using ultrasound to check eye measurements and see how they relate to alertness in patients with confusion or reduced awareness in the emergency department. 
Scientific Title of Study   Correlation of ultrasound guided pupillary and optic nerve sheath diameter with GCS in patients with altered mental status in the emergency. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akshay S Suresh 
Designation  Post Graduate Resident 
Affiliation  ABVIMS and Dr RML Hospital 
Address  Department of Emergency Medicine DR. RML Hospital New Delhi 110001

New Delhi
DELHI
110001
India 
Phone  9207783430  
Fax    
Email  akshay.s.suresh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Amlendu Yadav 
Designation  Head of Department 
Affiliation  ABVIMS and Dr RML Hospital 
Address  Head of Department Department of Emergency Medicine ABVIMS and Dr RML Hospital New Delhi 110001

New Delhi
DELHI
110001
India 
Phone  9711315438  
Fax    
Email  yadavamlendu@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Amlendu Yadav 
Designation  Head of Department 
Affiliation  ABVIMS and Dr RML Hospital 
Address  Head of Department Department of Emergency Medicine ABVIMS and Dr RML Hospital New Delhi 110001


DELHI
110001
India 
Phone  9711315438  
Fax    
Email  yadavamlendu@yahoo.co.in  
 
Source of Monetary or Material Support  
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. RML Hospital, Baba Kharak Singh Marg, Type III, Presidents Estate, New Delhi, Delhi, 110001 
 
Primary Sponsor  
Name  Akshay S Suresh 
Address  Post Graduate Resident Department of Emergency Medicine ABVIMS and Dr RML Hospital New Delhi 110001 
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 
Akshay S Suresh  ABVIMS and DR RML Hospital  ECS-Red Zone, Department of Emergency Medicine,Atal Bihari Vajpayee Institute of Medical Sciences and Dr. RML Hospital, Baba Kharak Singh Marg, Type III, Presidents Estate, New Delhi, Delhi, 110001
New Delhi
DELHI 
9207783430

akshay.s.suresh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee ABVIMS and DR RML Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R418||Other symptoms and signs involvingcognitive functions and awareness,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Age more than or equal to 18 years
2. Patients presenting with altered mental status. 
 
ExclusionCriteria 
Details  1. Severe ocular trauma, glaucoma, optic nerve abnormalities or conditions preventing accurate ultrasound.
2. History of significant ophthalmic pathology.
3. Inadequate ultrasound image quality.
4. Patients with pinpoint pupil on presentation.
5. Patients on topical ophthalmic drugs. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Correlation between pupillary diameter measured by ultrasound with Glasgow Coma Scale score in patients presenting with altered mental status in the emergency department.  Within 6 hour of admission. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Correlation between optic nerve sheath diameter measured by ultrasound with Glasgow Coma Scale score in patients presenting with altered mental status in the emergency department.
2.Correlation between pupillary diameter and optic nerve sheath diameter measured by ultrasound with Glasgow Coma Scale scores in patients presenting with altered mental status in the emergency department.
3.Differe in mean pupillary diameter and optic nerve sheath diameter across different levels of consciousness (mild, moderate, severe) as defined by GCS categories. 
Within 6 hour of admission. 
 
Target Sample Size   Total Sample Size="149"
Sample Size from India="149" 
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)   25/08/2025 
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 Applicable 
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  
This cross-sectional observational study aims to evaluate the correlation of ultrasound-measured pupillary diameter and optic nerve sheath diameter (ONSD) with the Glasgow Coma Scale (GCS) in patients presenting with altered mental status (AMS) to the Emergency Department of ABVIMS & Dr. RML Hospital, New Delhi. A total of 149 adult patients will be enrolled over a period of one year following approval from the Institutional Ethics Committee. Patients will be selected based on predefined inclusion and exclusion criteria and evaluated within 6 hours of presentation.
Following clinical assessment and GCS scoring, a standardized Point-of-Care Ultrasound (POCUS) technique will be used to measure bilateral ONSD and pupillary diameter. For each parameter, three measurements per eye will be recorded, and the mean value will be used for analysis. Data including patient demographics, clinical history, GCS, and ultrasound findings will be documented using a structured proforma. The correlation between ONSD, pupillary diameter, and GCS will be analyzed using appropriate statistical methods. 
The study is expected to provide valuable insights into the use of POCUS-based ocular measurements as objective, bedside indicators of neurological function. If a significant correlation is found, these ultrasound parameters could assist emergency physicians in early triage, diagnosis, and management of patients with AMS—especially in settings where neuroimaging is delayed or unavailable. By integrating these non-invasive tools into routine emergency practice, the study hopes to improve patient care through faster and more reliable neurologic assessments.
 
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