| 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
|
|
|
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
|
|
|
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. |