| CTRI Number |
CTRI/2026/01/100533 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Artificial Intelligence to Improve Emergency Department Triage |
|
Scientific Title of Study
|
Improving Emergency Triage with Machine Learning: Emergency Severity Index Score Prediction and Validation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Karthika Santhosh |
| Designation |
POST GRADUATE MD EMERGENCY MEDICINE |
| Affiliation |
Vinayaka Missions Kirupanandha Variyar Medical College and Hospital Salem |
| Address |
ROOM NO 100 Department of Emergency Medicine
Vinayaka Missions Kirupananda Variyar Medical College and Hospital Chinna Seeragapadi
Salem Tamil Nadu India Vinayaka Missions Kirupananda Variyar Medical College and Hospital Chinna Seeragapadi
Salem Tamil Nadu India Salem TAMIL NADU 636308 India |
| Phone |
8891569953 |
| Fax |
|
| Email |
drkarthikasanthosh@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Melvin Dominic |
| Designation |
Associate Professor Department of Emergency Medicine |
| Affiliation |
Vinayaka Missions Kirupanandha Variyar Medical College and Hospital Salem |
| Address |
ROOM NO 100 Department of Emergency Medicine
Vinayaka Missions Kirupananda Variyar Medical College and Hospital Chinna Seeragapadi
Salem Tamil Nadu India Vinayaka Missions Kirupananda Variyar Medical College and Hospital Chinna Seeragapadi
Salem Tamil Nadu India Salem TAMIL NADU 636308 India |
| Phone |
7904199406 |
| Fax |
|
| Email |
drmelvindominic@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Karthika Santhosh |
| Designation |
POST GRADUATE MD EMERGENCY MEDICINE |
| Affiliation |
Vinayaka Missions Kirupanandha Variyar Medical College and Hospital Salem |
| Address |
ROOM NO 100 Department of Emergency Medicine
Vinayaka Missions Kirupananda Variyar Medical College and Hospital Chinna Seeragapadi
Salem Tamil Nadu India Vinayaka Missions Kirupananda Variyar Medical College and Hospital Chinna Seeragapadi
Salem Tamil Nadu India Salem TAMIL NADU 636308 India |
| Phone |
8891569953 |
| Fax |
|
| Email |
drkarthikasanthosh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self-funded study. Infrastructure and clinical facilities were provided by Vinayaka Missions Kirupananda Variyar Medical College and Hospital, Salem, Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Kirupananda Variyar Medical College |
| Address |
Chinna Seeragapadi
Salem 636 308
Tamil Nadu
India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Karthika Santhosh |
Vinayaka Missions Kirupananda Variyar Medical College |
Room No 100,Emergency Medicine Department,Vinayaka Missions Kirupananda Variyar Medical College Chinna Seeragapadi
Salem
Tamil Nadu
India Salem TAMIL NADU |
8891569953
drkarthikasanthosh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 18–65 years presenting to the emergency department
Patients triaged using the Emergency Severity Index (ESI) by trained personnel
Availability of complete triage data including vital signs and chief complaints
Patients providing informed consent for use of de-identified data |
|
| ExclusionCriteria |
| Details |
Incomplete or missing triage data
Interfacility transfers or direct admissions without ED triage
Patients leaving against medical advice or leaving without being seen
Repeat ED visits of the same patient during the study period
Palliative or end-of-life care patients
Records with documented clerical or software errors |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accuracy of machine learning–predicted Emergency Severity Index (ESI) scores compared with nurse-assigned ESI scores, assessed at baseline triage during emergency department presentation and at the end of the study period (6 months) |
Baseline (at ED triage) and end of study (6 months)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in emergency department triage time before & after implementation of the machine learning–based triage tool, assessed at baseline (at emergency department presentation) & at the end of the study period (6 months) |
At ED presentation / triage
End of study: After completion of data collection (6 months) |
|
|
Target Sample Size
|
Total Sample Size="250" Sample Size from India="250"
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)
|
01/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/02/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" 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 prospective observational study aims to evaluate the effectiveness of a machine learning–based tool in predicting Emergency Severity Index (ESI) scores in an emergency department setting. Adult patients presenting to the emergency department will undergo routine triage by trained personnel using the ESI system. The tool will independently predict ESI scores using structured clinical data without influencing real-time patient management. The predicted scores will be compared with nurse-assigned ESI scores to assess accuracy and agreement. Secondary objectives include evaluating the impact of the tool on triage efficiency and inter-rater variability. The study seeks to determine whether machine learning can enhance consistency and accuracy in emergency triage while maintaining patient safety |