| CTRI Number |
CTRI/2025/07/090963 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparing two blood flow tests that measures SVR in patients undergoing major surgeries under GA |
|
Scientific Title of Study
|
Correlation of transpalmar resistivity index (TPRI) and snuff box resistivity index (SBRI) in patients undergoing major surgeries under general anaesthesia – A Cross-sectional study |
| 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 Pulkit Bansal |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Guwahati |
| Address |
Department of Anaesthesia, Critical Care and Pain Medicine, AIIMS Guwahati , Silbharal, Changsari
Kamrup
ASSAM
781101
India |
| Phone |
8602370903 |
| Fax |
|
| Email |
pulkitbansal2305@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dalim Kumar Baidya |
| Designation |
Professor and Head of the Department |
| Affiliation |
All India Institute of Medical Sciences, Guwahati |
| Address |
Department of Anaesthesia, Critical Care and Pain Medicine, AIIMS Guwahati , Silbharal, Changsari
Kamrup
ASSAM
781101
India |
| Phone |
9871568534 |
| Fax |
|
| Email |
dalimkumar.ab8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dalim Kumar Baidya |
| Designation |
Professor and Head of the Department |
| Affiliation |
All India Institute of Medical Sciences, Guwahati |
| Address |
Department of Anaesthesia, Critical Care and Pain Medicine, AIIMS Guwahati , Silbharal, Changsari
Kamrup
ASSAM
781101
India |
| Phone |
9871568534 |
| Fax |
|
| Email |
dalimkumar.ab8@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Guwahati, Silbharal, Changsari, Assam, India 781101 |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences Guwahati |
| Address |
All India Institute Of Medical Sciences, Guwahati, Silbharal, Changsari, Assam, India 781101 |
| 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 Pulkit Bansal |
All India Institute of Medical Sciences, Guwahati |
OT Complex, 2nd Floor IPD Block, Department of Anaesthesia, Critical Care and Pain Medicine
Kamrup
ASSAM |
8602370903
pulkitbansal2305@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Guwahati |
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients 18-65 yrs of age
ASA-PS I - III
Major elective non-cardiac surgery expected to last at least 2 hours under general anaesthesia
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the correlation between the mean SBRI and mean TPRI in patients undergoing major surgeries under general anesthesia. |
0 min, 10 min, 1 hr, 2hr, 3hr and 4hr and every 1hr till the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the agreement between the mean TPRI & mean SBRI |
0 minutes 10 minutes 1 hour 2hour 3hour 4 hour & every 1hour till the end of the surgery |
| To assess the number & percentage of patients where measurement of TPRI, or SBRI or both were not obtained, including the reasons for the same. |
0 minutes 10 minutes 1 hour 2hour 3hour 4 hour & every 1hour till the end of the surgery |
| To examine the relationship between TPRI & SBRI with the absolute change in mean arterial pressure (MAP) from baseline, the requirement for vasopressors, & the vasopressor inotrope score. |
0 minutes 10 minutes 1 hour 2hour 3hour 4 hour & every 1hour till the end of the surgery |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/08/2025 |
| 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 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
|
i am going to compare and correlate the already existing method of assessing SVR (systemic vascular resistance) which is snuffbox resistivity index and the novel approach that is transpalmar resistivity index. No previous study has been done on transpalmar resistivity index. Transpalmar resistivity index is easier to measure and probe placement is also easier and better and it is also less time consuming. I will enroll the patients as per my inclusion criteria and if the study and both parameters correlates well, then we can conduct further study on critically ill patients. |