| CTRI Number |
CTRI/2025/07/091383 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Screening |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To compare between Modified Allens test and Doppler ultrasonography for the assessment of collateral circulation of hand requiring surgery |
|
Scientific Title of Study
|
Comparison between Modified Allens test and Doppler ultrasonography for the assessment of collateral circulation of hand in patients requiring invasive BP monitoring during surgery. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priti Shreyash Devalkar |
| Designation |
Associate Professor |
| Affiliation |
Seth GS Medical college and KEM Hospital |
| Address |
Department of Anaesthesiology, Seth GS medical college and KEM Hospital,Parel, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
9769934980 |
| Fax |
|
| Email |
devalkarpriti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priti Shreyash Devalkar |
| Designation |
Associate Professor |
| Affiliation |
Seth GS Medical college and KEM Hospital |
| Address |
Department of Anaesthesiology, Seth GS medical college and KEM Hospital,Parel, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
9769934980 |
| Fax |
|
| Email |
devalkarpriti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sapna Maroti Sao |
| Designation |
Resident |
| Affiliation |
Seth GS Medical college and KEM Hospital |
| Address |
Department of Anaesthesiology, Seth GS medical college and KEM Hospital,Parel, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
8600171680 |
| Fax |
|
| Email |
saosapna1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| 1st floor, Department of Anaesthesiology, Seth GS Medical college and KEM Hospital ,Parel,Mumbai,Maharashtra-400012,India |
|
|
Primary Sponsor
|
| Name |
Seth G S Medical college and KEM Hospital |
| Address |
Acharya donde marg, Parel, Mumbai 400012 Maharashtra , India |
| 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 Priti Shreyash Devalkar |
KEM Hospital |
Department of Anaesthesiology, KEM Hospital, Acharya donde marg, Parel, Mumbai
Mumbai (Suburban)
MAHARASHTRA |
9769934980
devalkarpriti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC ll Relating to Biomedical and Health Research(BHR) Seth GS Medical College and KEM Hospital ,Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparing with Modified Allen’s test for the assessment of collateral circulation of hand |
Assessment of change in colour after releasing compression of ulnar artery |
| Intervention |
Doppler ultrasonography for the assessment of collateral circulation of hand in patients requiring invasive blood pressure monitoring during surgery. |
Assessment of peak systolic velocity of ulnar artery before and after radial artery compression and assessment of reversal of blood flow in thumb artery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 ASA I-III
2 Pt requiring invasive BP monitoring during
surgery |
|
| ExclusionCriteria |
| Details |
1 Pt not giving consent
2 Unstable hemodynamics
3 surgery or burn in upper limb or arteriovenous shunt
4 coagulopathy and bleeding disorder
5 pregnant and lactating women
6 arterial disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of collateral circulation of hand by modified Allens test and USG Doppler ultrasonography |
Baseline reading one day prior to surgery in recovery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare which is better for assesment of collateral circulation hand |
Secondary outcome of the study will be derived based on statistics after completion of sample size within given time |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/08/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Percutaneous radial artery canulation is usually used to facilitate perioperative invasive blood pressure management and frequent arterial blood gas determination during major surgeries. Although numerous studies have shown that radial artery cannulation has a low probability of complication but to minimize the risk of complication its important to assess collateral circulation of upper limb. The aim is to compare Modified Allen’s test (MAT) with Doppler ultrasonography to assess collateral circulation of upper limb in patient requiring invasive BP monitoring during surgery. In this study patients with age between 18-65 will be included, those who are willing to participate in the study , belonging to ASA I AND II undergoing elective surgery will be enrolled. Patient who are not giving consent, who are hemodynamically unstable, with coagulopathy or bleeding disorder will be excluded. After taking informed consent , after doing pre anesthesia checkup an OT anaesthetist wil perform Modified Allen’s test (MAT) and Anaesthetist with one year USG experience will perform Doppler ultrasonography of upper limb. Result of Modified Allen’s test will be recorded down. In Doppler ultrasonography we will calculate the peak systolic velocity of ulnar artery before and after compression of radial artery with that palmar arch test will be performed to see the reversal of blood flow after radial artery compression and the result will be recorded. This result of MAT and Doppler Ultrasonography will be compared
|