| 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
|
|
|
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
|
|
|
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. |