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CTRI Number  CTRI/2025/08/092629 [Registered on: 07/08/2025] Trial Registered Prospectively
Last Modified On: 07/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Comparison between IJV-SSCV Cannulation]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Two Types of Ultrasound Guided Central Line Placement in Patients Undergoing Major Elective Surgeries 
Scientific Title of Study   l Comparison Of Ultrasound -Guided Internal Jugular Vein And Supraclavicular Subclavian Vein -A Randomized Control Trial 
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sumit Chikara 
Designation  Major(Dr)PG Student 
Affiliation  Army Hospital Research and Referral 
Address  Department of Anaesthesiology and Critical Care, Army Hospital Research and Referral, Delhi Cantt, New Delhi
Department of Anaesthesiology and Critical Care, Army Hospital Research and Referral, Delhi Cantt, New Delhi
South West
DELHI
110010
India 
Phone  9205004537  
Fax    
Email  sumitchikara124@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Josemine Davis 
Designation  Col(Dr)Professor 
Affiliation  Army Hospital Research and Referral 
Address  Head Of Department , Department of Anaesthesiology and Critical Care, Army Hospital Research and Referral, Delhi Cantt, New Delhi
Department of Anaesthesiology and Critical Care, Army Hospital Research and Referral, Delhi Cantt, New Delhi
South West
DELHI
110010
India 
Phone  9764623542  
Fax    
Email  jose2mine@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Josemine Davis 
Designation  Col(Dr)Professor 
Affiliation  Army Hospital Research and Referral 
Address  Head Of Department , Department of Anaesthesiology and Critical Care, Army Hospital Research and Referral, Delhi Cantt, New Delhi
Department of Anaesthesiology and Critical Care, Army Hospital Research and Referral, Delhi Cantt, New Delhi
South West
DELHI
110010
India 
Phone  9764623542  
Fax    
Email  jose2mine@yahoo.com  
 
Source of Monetary or Material Support  
Army Hospital Research and Referral, Subroto Park, Dhaula Kuan, New Delhi, Delhi-110010, India 
 
Primary Sponsor  
Name  Josemine Davis 
Address  Department of Anaesthesiology and Critical Care Army Hospital Research And Referral New Delhi 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
Rohit Malhotra  Department of Anaesthesiology and Critical Care Army Hospital Research And Referral New Delhi 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSumit Chikara  Army Hospital Research And Referral  HOD Cabin,Department of Anaesthesiology and Critical Care Army Hospital Research And Referral New Delhi-110010
South West
DELHI 
9205004537

sumitchikara124@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Army Hospital (R&R),Delhi Cantt  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  USG Guided Comparisson between IJV and SSCV Cannulation  Position the patient in supine position with neck turned to either side .After clean drape the patient and USG machine prepared .The USG probe will be in sterile cover .IJV and SSCV will be identified .After randomisation either of the veins will be cannulated and the time for each will be noted from prick to successful cannulation and immediate complication will be noted 
Intervention  USG Guided Comparisson between IJV and SSCV Cannulation   Position the patient in supine position with neck turned to either side .After clean drape the patient and USG machine prepared .The USG probe will be in sterile cover .IJV and SSCV will be identified .After randomisation either of the veins will be cannulated and the time for each will be noted from prick to successful cannulation and immediate complication will be noted. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All adult patients from 18years to 80 years , undergoing all major elective surgeries .And patients who are able to provide consent are included in the study. 
 
ExclusionCriteria 
Details  Prior ipsilateral venous cannulation will not be included in the study.
Any contraindication to ultrasound guidance .
Pregnant patient not included in the study and patient on anticoagulation therapy also not included in the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
First attempt success rate and immediate complication such as hematoma , carotid artery puncture , pneumothorax.  20 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
Time of insertion & operator satisfaction.  10 minutes 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)   28/08/2025 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sumitchikara124@gmail.com].

  6. For how long will this data be available start date provided 01-09-2025 and end date provided 01-03-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Central venous cannulation (CVC) is a vital intervention in the operation theatre, intensive

care unit, and emergency room. Common clinical applications of CVC include central

venous pressure (CVP) monitoring in major surgeries, administration of drugs,

hyperosmolar solutions and blood products.

Internal jugular vein (IJV) cannulation being the most adopted route for central venous

access, it is associated with several problems like proximity to neck vessels leading to

arterial puncture, and difficulty in access in obese, edematous, and hypovolemic patients.

The subclavian vein is advantageous anatomically owing to its huge caliber, absence of

valves, and support of surrounding structures which keeps the vein patent even in shock.

Traditionally, the internal jugular vein (IJV) and subclavian vein have been the preferred sites

for central venous access.

With advances in technology, the use of ultrasound has become the standard of care in

medical practice overcoming the limitations of landmark-based techniques. Ultrasound allows

realtime visualization of the vein ensuring successful cannulation with fewer attempts and

less complication rate.However, the choice between these two approaches remains a

subject of clinical debate, especially with the advent of ultrasound guidance, which has

significantly improved the accuracy and safety of these procedures.

As anesthesiologist Tomasz Czarnik and co-authors (2009) say: “In conclusion, subclavian

venous cannulation via the supraclavicular approach is an excellent method of central venous

access in anesthesia. The procedure success rate and the significant complication rate are

comparable to other techniques of central venous cannulation especially to jugular access,

which is regarded by most physicians as the safest one. Mechanical ventilation is not a risk

factor associated with significant complications. The supraclavicular approach should be

considered, especially in neuroanesthesia, where the right jugular approach could be

associated with cerebral perfusion pressure reduction, intracranial pressure elevation, and

venous stasis. The supraclavicular approach seems to be more comfortable than the jugular

approach in a conscious patient. This method can be successfully and relatively safely used

as a primary or alternative technique when other catheterization sites are not available to

augment the spectrum of catheterization possibilities, even in mechanically ventilated

patients”.

This thesis aims to compare the efficacy, safety, and clinical outcomes of ultrasound-guided

internal jugular vein and supraclavicular subclavian vein cannulation.

 
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