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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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