| CTRI Number |
CTRI/2025/06/089407 [Registered on: 24/06/2025] Trial Registered Prospectively |
| Last Modified On: |
21/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study comparing the effect of elastic bandage (reverse esmarch bandage) method and tourniquet method on vein dilation measured using ultrasound |
|
Scientific Title of Study
|
Comparison of Reverse esmarch bandage technique and Conventional tourniquet technique in assessing peripheral venous dilation - An observational comparative 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 |
Jaiprakash J |
| Designation |
PG student |
| Affiliation |
SBV Deemed to be university |
| Address |
Department of Anaesthesiology, 2nd floor, Hospital block, Mahatma Gandhi medical college and research institute, Pondicherry
Pondicherry PONDICHERRY 607403 India |
| Phone |
9944564888 |
| Fax |
|
| Email |
jaiprakash.jp95@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
HEMANTHKUMAR VR |
| Designation |
Professor and HOD |
| Affiliation |
SBV Deemed to be university |
| Address |
Department of Anaesthesiology, 2nd floor, Hospital block, Mahatma Gandhi medical college and research institute, Pondicherry
Pondicherry PONDICHERRY 607403 India |
| Phone |
9944564888 |
| Fax |
|
| Email |
drvrhk@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
HEMANTHKUMAR VR |
| Designation |
Professor and HOD |
| Affiliation |
SBV Deemed to be university |
| Address |
Department of Anaesthesiology, 2nd floor, Hospital block, Mahatma Gandhi medical college and research institute, Pondicherry
Pondicherry PONDICHERRY 607403 India |
| Phone |
9944564888 |
| Fax |
|
| Email |
drvrhk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Mahatma Gandhi medical college and research institute, Pondicherry, India 607403 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi medical college and research institute |
| Address |
Department of Anaesthesiology, 2nd floor, Hospital block, Mahatma Gandhi medical college and research institute, Pondicherry |
| Type of Sponsor |
Private medical college |
|
|
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 Jaiprakash J |
Mahatma Gandhi medical college and research institute |
Department of Anaesthesiology, 2nd floor, Hospital block, Mahatma Gandhi medical college and research institute, Pondicherry Pondicherry PONDICHERRY |
9944564888
jaiprakash.jp95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal Healthy individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age above 18 years to 60 years of any gender
ASA 1 and 2
BMI between 18 to 35
|
|
| ExclusionCriteria |
| Details |
Patients with contraindications to venous cannulation like severe coagulopathy
Patients with a known allergy to Esmarch bandage materials
Patients with limb infections or significant skin conditions
Thrombosed or non collapsibility of veins identified by USG
History of deep vein thrombosis or any other vascular disorder
History of cardiac disease or migraine headaches
Pregnant or lactating females |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Depth, Horizontal diameter, vertical diameter, cross-sectional area, and vein circumference |
At 5 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ease of visibility
|
At 5 mins |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
07/07/2025 |
| 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="0" 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
|
The study will include participants who will undergo procedures under two different conditions Group A pre tourniquet and post tourniquet application and Group B pre esmarch and post esmarch application. Tourniquet bandage will be applied 5 to 6 cm above the cubital fossa and distal veins will be measured. Esmarch bandage will be applied over the proximal 2/3rd sparing distal 1/3rd of the limb for measuring the venous dilation. After informed consent the participants with the arms in anatomical position by the side a baseline recording of heart rate blood pressure and oxygen saturation will be noted. All the study participants will undergo a baseline assessment of the veins using USG. A vein either in the dorsal surface or anaesthestic vein which will be selected. A cross sectional image of the vein will be recorded with gentle pressure and site marked with a skin marker. If the vein appears thrombosed or does not exhibit collapsibility, then those participants will be excluded. Parameters observed will include Depth of vein Average of the Horizontal and vertical diameter Crosssectional area and Vein circumference. Improved visibility of the veins are then visualized using Wewell brand vein finder and the measurement of the vein parameters are done using Ultrasound. |