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CTRI Number  CTRI/2026/04/107331 [Registered on: 01/04/2026] Trial Registered Prospectively
Last Modified On: 27/03/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   ACCURACY OF PERIPHERAL PERFUSION INDEX,RESPIRATORY ADJUSTED SHOCK INDEX AND REVERSE SHOCK INDEX IN PREDICTING OCCULT HYPOPERFUSION IN TRAUMA PATIENTS 
Scientific Title of Study   Prospective observational cohort to predict accuracy of Peripheral Perfusion Index, Respiratory Adjusted Shock Index and Reverse Shock Index in predicting Occult Hypoperfusion in Trauma patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shivangi Sharma 
Designation  Fellow in Regional Anaesthesia 
Affiliation  Ganga Hospital and Medical Centre 
Address  Department of Anesthesiology and Perioperative Pain, Ganga hospital 313, Mettupalayam Road , Coimbatore, Tamil Nadu 641043
Department of Anesthesiology and Perioperative Pain, Ganga hospital 313, Mettupalayam Road , Coimbatore, Tamil Nadu
Coimbatore
TAMIL NADU
641043
India 
Phone  9810390606  
Fax    
Email  shivangibps@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shivangi Sharma 
Designation  Fellow in Regional Anaesthesia 
Affiliation  Ganga Hospital and Medical Centre 
Address  103-D Platinum Enclave DDA SFS Flats Sector-18 Rohini New Delhi
Department of Anesthesiology and Perioperative Pain, Ganga hospital 313, Mettupalayam Road , Coimbatore, Tamil Nadu
North West
DELHI
110089
India 
Phone  9810390606  
Fax    
Email  shivangibps@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shivangi Sharma 
Designation  Fellow in Regional Anaesthesia 
Affiliation  Ganga Hospital and Medical Centre 
Address  103-D Platinum Enclave DDA SFS Flats Sector-18 Rohini New Delhi
Department of Anesthesiology and Perioperative Pain, Ganga hospital 313, Mettupalayam Road , Coimbatore, Tamil Nadu 641043
North West
DELHI
110089
India 
Phone  9810390606  
Fax    
Email  shivangibps@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Shivangi Sharma 
Address  103-D Platinum Enclave DDA SFS Flates Sector-18 Rohini New Delhi 
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 
DrAnjali Peeceeyen  Ganga Hospital and Medical Centre  Department of Anesthesiology and Perioperative Pain, Ganga hospital 313, Mettupalayam Road , Coimbatore, Tamil Nadu 641043
Coimbatore
TAMIL NADU 
8667367165

anjalipeeceeyenster@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ganga Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.The study will include adult trauma patients (aged 18 years- 75 years)
2.Trauma patients ASA Grade I and II
3.Vitals recordable
4.Open injury
 
 
ExclusionCriteria 
Details  1.Age <18 yrs
2.Trauma patients with ASA III and IV
3.Vitals not recordable
4.Closed injuries
5.Traumatic arrest/ Overt shock
6.Patients will be excluded if they have a known history of severe cardiac or pulmonary disease, are pregnant, present in frank cardiac arrest, or have received blood products or significant vasopressor medications in the pre-hospital setting.
7.Patients with isolated traumatic brain injury without evidence of systemic trauma will also be excluded.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the predictive accuracy of the Peripheral Perfusion Index (PPI), Respiratory Adjusted Shock Index (RASI), and Reverse Shock Index (RSI) for identifying occult hypoperfusion   To evaluate the predictive accuracy of the Peripheral Perfusion Index (PPI), Respiratory Adjusted Shock Index (RASI), and Reverse Shock Index (RSI) for identifying occult hypoperfusion  
 
Secondary Outcome  
Outcome  TimePoints 
To determine the optimal cut-off values for PPI, RASI, & RSI that best predict occult hypoperfusion & adverse clinical outcomes (e.g., need for massive transfusion, ICU admission, mechanical ventilation, or mortality).
 
Day 0 of arrival
24 hours post arrival 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)  15/04/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
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  

Primary Objective

To evaluate the predictive accuracy of the Peripheral Perfusion Index (PPI), Respiratory Adjusted Shock Index (RASI), and Reverse Shock Index (RSI) for identifying occult hypoperfusion (defined by a serum lactate level > 2 mmol/L or a base deficit <-2 mEq/L) in trauma patients upon arrival at the casualty.

Secondary Objectives

1.To compare the predictive performance of each index (PPI, RASI, and RSI) against the traditional Shock Index (SI) in detecting occult hypoperfusion.

2.To determine the optimal cut-off values for PPI, RASI, and RSI that best predict occult hypoperfusion and adverse clinical outcomes (e.g., need for massive transfusion, ICU admission, mechanical ventilation, or mortality).

PLACE OF STUDY:


This study will be conducted in Ganga Medical Center and Hospital, Coimbatore Level I trauma centre which manages a high volume of severely injured patients


Methodology: 

Upon arrival at the trauma bay, the following data would be collected:

Standard vital signs (heart rate, systolic blood pressure, respiratory rate).

Clinical indices (PPI, RASI, and RSI) would be calculated or measured.

Injury characteristics and mechanism of injury.(ISS, RTS)

Simultaneously, point of care lactate levels will be measured by drawing a blood sample within 15-20 minutes of arrival to Trauma Bay

Measurements will be taken pre and post operatively . 

Outcomes would be recorded post operatively will also include:

1.Need for massive transfusion protocol activation pre/intra/post operatively

2.Length of stay in the Intensive Care Unit (ICU) and hospital.?

3.Incidence of complications (e.g., acute kidney injury, acute respiratory distress syndrome).

4.Mortality.

5.Post op lactate values indices



 
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