| CTRI Number |
CTRI/2025/03/081876 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing Pain in critically ill patients by the evaluation of Perfusion Index derived by oximetry in postoperative patients admitted in surgical ICU. |
|
Scientific Title of Study
|
Assessing pain in critically ill patients by the evaluation of Perfusion Index on postoperative patients admitted to the surgical ICU at the Department of Anaesthesiology and Critical Care, AIIMS, Nagpur. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lakshay Rana |
| Designation |
junior resident |
| Affiliation |
Dept of Anaesthesiology and Critical care Aiims Nagpur |
| Address |
1st floor, OT Complex, Dept of Anaesthesiology and Critical care Aiims Nagpur
Nagpur MAHARASHTRA 441108 India |
| Phone |
8813091700 |
| Fax |
|
| Email |
lakshayrana1996@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sucheta Meshram |
| Designation |
Associate Professor |
| Affiliation |
Dept of Anaesthesiology and Critical Care AIIMS Nagpur |
| Address |
1st floor , OT Complex, Dept of Anaesthesiology and Critical care AIIMS Nagpur
Nagpur MAHARASHTRA 441108 India |
| Phone |
|
| Fax |
|
| Email |
sucheta1021@aiimsnagpur.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Sucheta Meshram |
| Designation |
Associate professor |
| Affiliation |
Dept of Anaesthesiology and Critical care AIIMS Nagpur |
| Address |
1st floor, OT Complex,Dept of Anaesthesiology and Critical care AIIMS Nagpur
MAHARASHTRA 441108 India |
| Phone |
|
| Fax |
|
| Email |
sucheta1021@aiimsnagpur.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology & Critical Care, AIIMS Nagpur |
|
|
Primary Sponsor
|
| Name |
AIIMS Nagpur |
| Address |
Department of Anaesthesiology and Critical Care AIIMS Nagpur Mihan 441108 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Lakshay Rana |
AIIMS Nagpur |
Department of Anaesthesiology and Critical Care AIIMS Nagpur Mihan 441108 Nagpur MAHARASHTRA |
8813091700
lakshayrana1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Postoperative adult patients admitted in the surgical ICU |
|
| ExclusionCriteria |
| Details |
Amputed patients, patients with steep inotropic support, peripheral vascular disease and any factor affecting microcirculation in the limb shall be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the co-relation of perfusion index with pain levels. |
at baseline (admission to ICU), 12 hours and 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
10/03/2025 |
| 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 study aims to investigate the
utility of the perfusion index (PI) as an objective tool for pain assessment in
critically ill postoperative patients admitted to the surgical ICU. Pain
management is a crucial component of care in such patients, but conventional
methods like the Visual Analog Scale (VAS) and Behavioral Pain Scale-Non
Intubated (BPS-NI) often have limitations due to the subjective nature of their
measurements, especially in patients who are non-verbal or have altered mental
status.
The perfusion index (PI), derived
from photoplethysmography (PPG), offers a potential solution. It is a
non-invasive method that measures peripheral blood flow, providing real-time
data on the patient’s hemodynamic status. Since stress responses to pain can
affect peripheral circulation, PI may serve as an indirect indicator of pain
levels. This study will evaluate the correlation between PI and traditional
pain scales, such as VAS and BPS-NI, to determine whether PI can provide a
reliable and objective assessment of pain in critically ill patients. By
establishing a correlation between PI and conventional pain metrics, the
research aims to improve pain management strategies in the ICU, potentially
leading to better patient outcomes, reduced complications, and enhanced
comfort. |