| 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
|
|
|
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
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ganga Hospital Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
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.
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|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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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
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|
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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