| CTRI Number |
CTRI/2025/07/091989 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two ultrasound guided approaches for cannulation Of neck vein which is internal jugular vein in adult patients undergoing surgery. |
|
Scientific Title of Study
|
Comparison of Short Axis Approach with Dynamic Needle Tip Positioning and Oblique Axis Approach for ultrasound guided cannulation Of Internal Jugular Vein in adult patients undergoing elective surgery under general anaesthesia. |
| 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 Pooja |
| Designation |
Post Graduate student |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia hospital |
| Address |
room no 301 3rd floor Department of anaesthesia, ABVIMS and Dr. RML hospital, Baba Kharak Singh marg, near gurudwara Bangla sahib, connaught place, New Delhi
New Delhi DELHI 110001 India |
| Phone |
7087790662 |
| Fax |
|
| Email |
heena51197@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Neerja Banerjee |
| Designation |
Professor and Head of department |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia hospital |
| Address |
room no 301 3rd floor Department of anaesthesia, ABVIMS and Dr. RML hospital, Baba Kharak Singh marg, near gurudwara Bangla sahib, connaught place, New Delhi
New Delhi DELHI 110001 India |
| Phone |
9810517575 |
| Fax |
|
| Email |
neerja.banerjee@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Aanchal Kakkar |
| Designation |
Professor |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia hospital |
| Address |
room no 301 3rd floor Department of anaesthesia, ABVIMS and Dr. RML hospital, Baba Kharak Singh marg, near gurudwara Bangla sahib, connaught place, New Delhi
New Delhi DELHI 110001 India |
| Phone |
9899368080 |
| Fax |
|
| Email |
kakkaraanchal02@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia hospital, Baba Kharak Singh marg, New Delhi, Delhi, India, pin 110001 |
|
|
Primary Sponsor
|
| Name |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia hospital |
| Address |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia hospital, Baba Kharak Singh Marg, Connaught place, New Delhi 110001 |
| Type of Sponsor |
Government 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 Pooja |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital |
Department of Anaesthesia, Kharak Singh Marg, near Bangla Sahib, Connaught place New Delhi DELHI |
7087790662
heena51197@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ABVIMS and Dr. RML hospital, New Delhi |
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 |
Oblique axis approach for ultrasound guided cannulation of internal jugular vein |
Oblique axis approach for ultrasound guided cannulation Of Internal Jugular Vein in adult patients undergoing elective surgery under general anaesthesia |
| Comparator Agent |
Short Axis Approach with Dynamic Needle Tip Positioning for Ultrasound guided cannulation of Internal Jugular Vein |
Short Axis Approach with Dynamic Needle Tip Positioning for ultrasound guided cannulation Of Internal Jugular Vein in adult patients undergoing elective surgery under general anaesthesia |
| Intervention |
Ultrasound guided cannulation of internal jugular vein |
Short Axis Approach with Dynamic Needle Tip Positioning and Oblique Axis approach for ultrasound guided cannulation Of Internal Jugular Vein in adult patients undergoing elective surgery under general anaesthesia. Total duration of procedure will be taken as time from skin puncture to confirmed intraluminal guidewire or catheter placement which is first attempt success rate.The total duration of IJV cannulation is expected to be approximately 3–5 minutes under ultrasound guidance in a single successful attempt. In case of difficulty or multiple attempts, the duration may extend, but no fixed upper time limit is defined in the study protocol. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
adult patients including both gender (Age 18 year or older), ASA class I, II, III, scheduled for elective surgery under general anaesthesia requiring internal jugular vein cannulation will be enrolled for the study. |
|
| ExclusionCriteria |
| Details |
1. Patients with coagulopathy
2. Thrombosed right IJV
3. History of previous cannulation of IJV
4. Patients on anticoagulant drugs
5. BMI greater than 30
6. Patients with tracheostomy
7. Patients with neck scar near right IJV
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| First attempt success rate |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| successful cannulation time |
At baseline |
| number of attempts for successful cannulation |
Total number of attempts taken for placement of catheter at baseline |
| complications like hematoma, posterior wall puncture, vasospasm etc |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="104" Sample Size from India="104"
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)
|
20/08/2025 |
| 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="5" 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 purpose of this study is to compare two ultrasound guided techniques for placing a central line into the internal jugular vein in adults having elective surgery under general anesthesia. It aims to find out which method is more successful on the first attempt, takes less time, needs fewer attempts, and has fewer complications. This study will include patients who need internal jugular vein cannulation. After explaining the procedure, written consent will be obtained from the patient or their relatives. Patients will be randomly divided into two groups using sealed envelopes. Standard monitoring will include ECG, blood pressure, and oxygen levels. General anesthesia will be given using propofol, fentanyl, and vecuronium. After intubation, anesthesia will be maintained with oxygen, nitrous oxide, and sevoflurane. Cannulation will be done on the right internal jugular vein with the patient in a slight head-down position and the head turned to the opposite side. The procedure will be guided by real-time ultrasound using a high-frequency probe. Group I which is Short Axis with Dynamic Needle Tip Positioning, the ultrasound probe will show a cross-sectional view of the vein. The needle will be advanced slowly in small steps while keeping the tip visible on the screen. Once the tip is inside the vein and blood return is seen, a guidewire will be inserted. The needle will be removed, the path will be widened, and a catheter will be placed over the guidewire. Group II which is Oblique Axis Approach, an oblique view of the vein will be used. The needle will be inserted in line with the ultrasound beam, so the entire needle is visible. The needle will be guided into the vein while continuously watching the tip. Once blood return is confirmed, the guidewire, dilator, and catheter will be placed as in the first group. After the procedure, an X-ray or ultrasound will be used to confirm catheter position and rule out complications. Data collected will include patient details, reason for cannulation, success on first attempt, number of attempts, use of ultrasound, time taken, and any complications like artery puncture, hematoma, pneumothorax, misplacement, or infection. |