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CTRI Number  CTRI/2026/04/107328 [Registered on: 01/04/2026] Trial Registered Prospectively
Last Modified On: 31/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A comparative study of two trauma scoring systems(rSI-SMS versus rSIG) in predicting outcomes for polytrauma patients presenting in trauma triage. 
Scientific Title of Study   TO COMPARE REVERSE SHOCK INDEX- SIMPLIFIED MOTOR SCORE(rSI-SMS) VERSUS REVERSE SHOCK INDEX- GLASGOW COMA SCORE(rSIG) FOR POLYTRAUMA PATIENTS PRESENTING IN TRAUMA TRIAGE. 
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 Monica Chhikara 
Designation  Professor 
Affiliation  Pt BD Sharma PGIMS, Rohtak  
Address  Room no 26, Second floor, New Modular OT cum ICU Complex, Department of Anaesthesiology and Critical Care Pt BD Sharma PGIMS, Rohtak
Room no 26,Second floor, New Modular OT cum ICU Complex, Department of Anaesthesiology and Critical Care Pt BD Sharma PGIMS, Rohtak
Rohtak
HARYANA
124001
India 
Phone  9468465746  
Fax    
Email  chhikara.monica@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Varinda 
Designation  Junior Resident 
Affiliation  Pt BD Sharma PGIMS, Rohtak  
Address  Department of Anaesthesiology and Critical Care Pt BD Sharma PGIMS, Rohtak
Department of Anaesthesiology and Critical Care Pt BD Sharma PGIMS, Rohtak
Rohtak
HARYANA
124001
India 
Phone  9729542710  
Fax    
Email  varindaballu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Varinda 
Designation  Junior Resident 
Affiliation  Pt BD Sharma PGIMS, Rohtak 
Address  Department of Anaesthesiology and Critical care Pt BD Sharma PGIMS, Rohtak
Department of Anaesthesiology and Critical care Pt BD Sharma PGIMS, Rohtak
Rohtak
HARYANA
124001
India 
Phone  9729542710  
Fax    
Email  varindaballu@gmail.com  
 
Source of Monetary or Material Support  
Pt. B.D. Sharma, PGIMS Rohtak, Haryana, 124001 
 
Primary Sponsor  
Name  Pt BD Sharma PGIMS Rohtak Haryana 
Address  Pt. B.D. Sharma, PGIMS Rohtak, Haryana 
Type of Sponsor  Government medical college 
 
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 Varinda  Pt BD Sharma PGIMS, Rohtak  Department of Anaesthesiology and Critical care
Rohtak
HARYANA 		 9729542710

varindaballu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BIOMEDICAL ETHICS RESEARCH COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: PCS||,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient with age more than 18years and less than 60 years
Polytrauma patients with ISS more than 15 
 
ExclusionCriteria 
Details  Patient with age less than 18 years
Patients who are already intubated or tracheostomized
Patients who have history of cardiac arrest
Patients on vasopressors
Known cases of compromised left ventricular systolic function
Patients with minor injuries
Polytrauma more than 48 hours
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
TO EVALUATE THE PREDICTIVE ABILITY OF TWO SCORE (rSI-SMS and rSIG) FOR THE NEED OF MECHANICAL VENTILATION IN POLYTRAUMA PATIENTS.  ASSESSMENT OF HEART RATE, BLOOD PRESSURE, GLASGOW COMA SCORE AND SIMPLIFIED MOTOR SCORE AT THE TIME OF PRESENTATION AND THEN ONCE DAILY FOR TEN DAYS. 
 
Secondary Outcome  
Outcome  TimePoints 
1.COMAPRING THE TWO SCORES rSI-SMS AND rSIG IN PREDICTING THE NEED FOR VASOPRESSOR SUPPORT IN POLYTRAUMA PATIENTS.
2. COMPARING TWO SCORES i.e., rSI-SMS AND rSIG IN PREDICTING THE DURATION OF ICU STAY. 		 1.ICU ADMISSION RATE (FROM PRESENTATION TILL 10 DAYS)
 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   15/04/2026 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   TITLE

To compare Reverse Shock Index-Simplified Motor Score(rSI-SMS) Versus Reverse Shock Index-Glasgow Coma Score (rSIG) for polytrauma patients presenting in trauma triage

AIM

To compare reverse shock index-simplified motor score(rSI-SMS) and reverse shock index-Glasgow coma score (rSIG) for prediction of need for mechanical ventilation, vasopressors and ICU stay in polytrauma patients.

OBJECTIVE

Primary objective

1.     To compare reverse shock index-simplified motor score (rSI-SMS) and reverse shock index-Glasgow coma score (rSIG) for their correlation with need of mechanical ventilation in polytrauma patients.

Secondary objectives

1.     To compare the two scores rSI-SMS and rSIG, for prediction of hemodynamic instability requiring vasopressors in polytrauma patients

2.     To compare two scores, rSI-SMS and rSIG in predicting the length of ICU stay in polytrauma patients.

Inclusion Criteria:

1.  Patient with age >18 years and <60 years

2.  Polytrauma patients with injury severity score>15.

Exclusion Criteria:

1. Patient with age <18 years.

2. Patients who are already intubated/tracheostomized.

3. Patients who have history of cardiac arrest.

4. Patients on vasopressors.

5. Known cases of compromised left ventricular systolic function.

6. Patient with minor injuries.

7. Polytrauma more than 48 hours.

SAMPLE SIZE: 120 patients of polytrauma presenting in trauma triage.

ASSESSMENT : a) General Examination: head to toe

b) Respiratory System: RR,sPO2

c) Cardiovascular system : HR, SBP, rSI

       d)Neurological system : GCS, SMS, MOTOR, SENSORY 

Reverse shock index – Glasgow coma score (rSIG)

Reverse shock index-Simplified motor score (rSI-SMS)

e) GIT

f) Skin

g) Pupils

h) Blood gas analysis

Oxygenation:

Ventilatory support (required or not):

If required, ventilator settings:

Fluids

a)     Per oral /Ryles tube

b)     Intravenous

a)     Urine output

b)     Drains

Infusions

a)     Vasopressors

a)     Sedation 

Blood sugar charting:

ICU stay (+/-):

If yes, No.of days:

Critical event (if any):

Mortality: 

ANALYSIS : Data will be compiled and appropriate statistical test will be applied for results.

 


 
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