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CTRI Number  CTRI/2025/03/083272 [Registered on: 24/03/2025] Trial Registered Prospectively
Last Modified On: 21/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison between different approaches for Subclavian Vein Catheterisation 
Scientific Title of Study   Comparison of Ultrasound guided Subclavian vein catheterisation using Supracvlavicular V/S Infraclavicular approach: a Randomised Controlled trial 
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 Sarfaraz Ahmed 
Designation  Professor 
Affiliation  Rohilkhand Medical College and Hospital 
Address  Department of Anesthesia, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly, Uttar Pradesh 243006 India

Bareilly
UTTAR PRADESH
243006
India 
Phone  9027347787  
Fax    
Email  sarfaraz_ahm2000@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sarfaraz Ahmed 
Designation  Professor 
Affiliation  Rohilkhand Medical College and Hospital 
Address  Department of Anesthesia, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly, Uttar Pradesh 243006 India


UTTAR PRADESH
243006
India 
Phone  9027347787  
Fax    
Email  sarfaraz_ahm2000@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vikalp Dahiya 
Designation  Junior Resident 
Affiliation  Rohilkhand Medical college and Hospital 
Address  Department of Anesthesia, Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly, Uttar Pradesh 243006 India

Bareilly
UTTAR PRADESH
243006
India 
Phone  8800321301  
Fax    
Email  vikalpdahiya5960@gmail.com  
 
Source of Monetary or Material Support  
Rohilkhand Medical College and Hospital,Bareilly, Uttar Pradesh 243006, India 
 
Primary Sponsor  
Name  Rohilkhand Medical College and Hospital  
Address  Rohilkhjand Medical college and Hospital, Pilibhit bypass road, Bareilly, Uttar Pradesh, 243006, India 
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 Sarfaraz Ahmad  Rohilkhand Medical College and Hospital  243006E Department of Anesthesiology Rohilkhand Medical College and Hospital, Bareilly Uttar Pradesh India
Bareilly
UTTAR PRADESH 
09027347787

sarfaraz_ahm2000@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, RMCH, Bareilly, U.P  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  Infraclavicular approach  After the induction of general anesthesia using sterile measures, the region will be prepped with betadine and draped. After that, while in supine position a sandbag will be placed in between the shoulder blades of patient. We will place USG machine on left side of patient. One anaesthesiologist will perform the procedure while standing on the right side of the patient and second anaesthesiologist will record the data. While maintaining aseptic conditions, modified Seldinger technique will be used to put a 7 Fr Triple lumen cannula in the SCV.  
Intervention  Supraclavicular approach  After the induction of general anesthesia using sterile measures, the region will be prepped with betadine and draped. After that, while in supine position a sandbag will be placed in between the shoulder blades of patient. We will place USG machine on left side of patient. One anaesthesiologist will perform the procedure while standing on the right side of the patient and second anaesthesiologist will record the data. While maintaining aseptic conditions, modified Seldinger technique will be used to put a 7 Fr Triple lumen cannula in the SCV. The total duration of procedure will be 5-6 minutes  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grade I,II,III 
 
ExclusionCriteria 
Details  1. History of prior catheterization at the same site,
2. Local site infection,
3. Contralateral pneumothorax,
4. Clavicle and the upper ribs injury,
5. Distortion of neck anatomy (burns),
6. Cervical spine injury,
7. Known vascular abnormality,
8. Coagulopathy,
9 Uncontrolled hypertension,
10.More than three attempts at needle puncture.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare efficacy of the two approach for Subclavian vein catheterisation in terms of :

1.Total access time
2.Catheter insertion time
3.Number of attempts of needle advances to puncture vein
4.Number of attempts in guidewire insertion
5.Rate of successful cannulation
6.Quality of needle visualisation
 
Time taken to successfully place the catheter will be noted which will be 5-7 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable   
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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   Phase 4 
Date of First Enrollment (India)   11/04/2025 
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  

Central venous catheterization (CVC) is required for the purposes of CVP monitoring, transvenous cardiac pacing, hemodialysis access, cancer patients with difficult venous access,  chemotherapy, sick patients, volume resuscitation and patients undergoing major surgery.
The IJV, subclavian, and femoral veins are the mainly three large venous routes for central line insertion; each has pros, cons, and possible difficulties of its own.

When it comes to central venous catheterization, subclavian vein catheterization (SCV) is the preferred option over internal jugular veins (IJVs) for a number of reasons. These include a lower risk of infection when compared to femoral or internal jugular sites, ease of placement for patients who are immobilized due to severe trauma, less interference during endotracheal intubation, mechanical ventilation during Cardiopulmonary Cerebral Resuscitation (CPCR), and reduced patient discomfort when receiving long-term intravenous treatment. In comparison to internal jugular vein or femoral vein cannulation, it also carries a lower risk of thrombosis. When  hypovolemic shock occurs, this large diameter vein frequently stays patent due to the surrounding support structures. As the SCV is located very close to  structures like  subclavian artery and lungs, SCV cannulation can cause  complications such as subclavian artery puncture causing hematoma, hemothorax and pneumothorax. USG guided approach is superior to landmark guided approach.

The benefit includes an increase success rate, great efficiency and decreased complications.

CVC under direct vision using USG needs a lesser number of attempts, decreases the time required for insertion, and reduces complications like accidental arterial puncture, pnemothorax, and wrong guidewire position . SCV can be cannulated by supraclavicular and infraclavicular approaches.

The supraclavicular approach have advantage over infraclavicular approach such as a well defined insertion landmark, a shorter skin to vein distance, a larger target area, a straighter path to superior vena cava, less proximity to the lung, and fewer complications of pleural and arterial puncture.

The study will be carried out as there is scarcity of literature on comparison of USG guided Supraclavicular  and Infraclavicular approach for Subclavian vein cannulation so the relative efficacy of one over the other is debatable. By shedding light on comparative merits of Supraclavicular and Infraclavicular approach, this investigation will help anaesthetic practitioners in choosing a better treatment plan for the patients.

Therefore this study is to compare Infraclavicular approach to Supraclavicular approach for ease of subclavian vein cannulation under ultrasound guidance.

 
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