| CTRI Number |
CTRI/2018/05/013751 [Registered on: 08/05/2018] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative efficacy of two different approaches of Subclavian vein cannulation under ultrasound guidance |
|
Scientific Title of Study
|
Comparative efficacy of Supraclavicular versus Infraclavicular approach of Subclavian vein cannulation under ultrasound guidance: A randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
T Mageshwaran |
| Designation |
Post Graduate Resident |
| Affiliation |
AIIMS |
| Address |
Department of Anesthesiology
All India Institute of Medical Sciences
Virbhadra Road, Near Barrage, Rishikesh, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8077447687 |
| Fax |
|
| Email |
mageprathika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepak Singla |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS |
| Address |
Department of Anesthesiology
All India Institute of Medical Sciences
Virbhadra Road, Near Barrage, Rishikesh, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8077447687 |
| Fax |
|
| Email |
deepak10.4u@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
T Mageshwaran |
| Designation |
Post Graduate Resident |
| Affiliation |
AIIMS |
| Address |
Department of Anesthesiology
All India Institute of Medical Sciences
Virbhadra Road, Near Barrage, Rishikesh, Uttarakhand
UTTARANCHAL
249203
India |
| Phone |
8077447687 |
| Fax |
|
| Email |
mageprathika@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
Virbhadra Road, Near Barrage, Rishikesh, Uttarakhand 249203
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| T Mageshwaran |
AIIMS Rishikesh |
Department of Anesthesiology, Medical college building, All India Institute of Medical Sciences, Virbhadra Road, Near Barrage, Rishikesh, Uttarakhand 249203
Dehradun
UTTARANCHAL |
8077447687
mageprathika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Posted for elective or emergency surgeries requiring Central venous catheter insertion, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Infraclavicular subclavian vein cannulation |
Infraclavicular subclavian vein cannulation using ultrasound in long axis till first blood is visible in the hub of needle (usually less than 15 sec) |
| Intervention |
Supraclavicular subclavian vein cannulation |
Supraclavicular subclavian vein cannulation using ultrasound in long axis till first blood is visible in the hub of needle (usually less than 15 sec) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are undergoing elective or emergency surgeries requiring central venous catheter insertion |
|
| ExclusionCriteria |
| Details |
Refusal to consent for study, bleeding disorders, uncontrolled hypertension, severe COPD, vascular malformations, severe cardiac disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the puncture time between infraclavicular and supraclavicular approaches under USG guidance |
time measured from start of procedure to the first appearance of blood in the syringe |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the number of attempts required for each approach |
Number of times needle is withdrawn and reinserted |
| To assess incidence of complications such as pneumothorax and arterial puncture |
From skin puncture to end of surgery |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients who are undergoing elective and emergency surgeries requiring central venous catheterization under general anaesthesia will be scanned for eligibility criteria, those fulfilling eligibility criteria, after explaining the procedure and purpose of the study ,written informed consent will be obtained and will be randomized into 2 groups by using computer generated random number technique.
Upon arrival in the operating room, standard monitoring including electrocardiogram (ECG), Non-invasive arterial blood pressure (NIBP), heart rate (HR) and pulse oximetry (SpO2) will be applied and adequate peripheral venous access will be established. General Anesthesia will be induced and after administration of muscle relaxant and patient will be intubated and mechanically ventilated. Anesthesia will be maintained with inhalational agents. All procedures will be performed on the right subclavian vein by a qualified anesthesiologist with an experience of at least 25 procedures using both the approaches for ultrasound guided subclavian vein catheterization. A post graduate junior resident will be recorded the puncture time, number of attempts, catheter insertion time and incidence complications. All times will be measured in seconds.Ultrasound with linear probe will be used for this study. In supraclavicular long axis approach, the internal jugular vein will be traced down the neck under ultrasound guidance and after reaching the internal jugular vein-subclavian vein junction, the probe will be turned laterally to obtain the longitudinal images of the subclavian vein. In infraclavicular long axis approach, ultrasound probe will be positioned almost parallel moving away from the clavicle and the entry point of the needle will be in plane with the probe. With this approach, only the subclavian visible on the screen. The needle will be hold at 45 degree angle, will be oriented in plane with transducer and the skin will be punctured at the base of the transducer. The vein alignment will be maintained during the procedure and the entire length of the needle will be visible during the progression through the tissues. Entry of the tip into the vein will be confirmed by blood aspiration. |