| CTRI Number |
CTRI/2025/07/089934 [Registered on: 01/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
comparison between different ultrasound guided approaches for central venous cannulation |
|
Scientific Title of Study
|
A Comparative study of ultrasound guided central venous
cannulation through internal jugular vein in plane, out of plane and lateral oblique
approaches- A prospective single blinded randomised controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VASANTHA RAO BANOTH |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Nizmas Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Nizams Institute of Medical Sciences, Hyderabad, India.
Hyderabad
TELANGANA
500082
India
Hyderabad TELANGANA 500082 India |
| Phone |
8247474271 |
| Fax |
|
| Email |
vasanth080698@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Prasad Rao Kaluvala |
| Designation |
Additional Professor |
| Affiliation |
Nizmas Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Nizams Institute of Medical Sciences, Hyderabad, India.
Hyderabad
TELANGANA
500082
India
Hyderabad TELANGANA 500082 India |
| Phone |
92462 70727 |
| Fax |
|
| Email |
drkprasadrao@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
VASANTHA RAO BANOTH |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Nizmas Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Nizams Institute of Medical Sciences, Hyderabad, India.
Hyderabad
TELANGANA
500082
India
TELANGANA 500082 India |
| Phone |
8247474271 |
| Fax |
|
| Email |
vasanth080698@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizmas Institute of Medical Sciences, Hyderabad, Telangana, India-500082 |
|
|
Primary Sponsor
|
| Name |
Nizmas Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Nizams Institute of Medical Sciences (NIMS), Hyderabad, Telangana, India-500082 |
| 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 |
| Vasantha Rao Banoth |
Nizmas Institute of Medical Sciences |
Main Operation Theatre - Old Building, Speciality Block Operation Theatre, Department of Anaesthesiology, Hyderabad, TELANGANA Hyderabad TELANGANA |
8247474271
vasanth080698@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS INSTITUTIONAL ETHICS COMMITTEE |
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 |
Ultrasound-guided central venous cannulation in in-plane, lateral oblique Approaches |
Central venous cannulation is performed using in-plane approch, where the needle is visualized along with its entire length , in lateral oblique approach ultrasound sound probe is positioned at an oblique angle to optimize visualization of both the vein and needle path |
| Intervention |
Ultrasound-guided central venous cannulation via internal jugular vein - out-of-plane Approach |
Central venous cannulation is performed using the out-of-plane Approach, where the needle is seen only in cross section as it intersect the ultrasound beam. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18 years or older.
2. Indicated for internal jugular venous
cannulation.
3. Informed consent.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the least amount of time taken from skin prick to ijv cannulation |
from time to skin prick to confirmation of cannula postion in IJV after aspiration from all the three ports. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the incidence of complications between the three approaches
2. To compare the best view and ease of cannulation on the Likert scale
3. To compare the total number of attempts required for cannulation between three approaches
|
from time to skin prick to confirmation of cannula postion in IJV after aspiration from all the three ports. |
|
|
Target Sample Size
|
Total Sample Size="400" Sample Size from India="400"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/07/2025 |
| 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="0" 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 - NO
|
|
Brief Summary
|
IJV cannulation is one of the most commonly performed procedures in the perioperative period and intensive care unit because of its anatomical position, large diameter in the Trendelenburg position, palpable surface landmarks, and short, straight, valveless course to the SVC and right atrium. The traditional approach to IJVC is based on anatomical landmarks, but ultrasound-guided central venous catheter placement increases the success rate, reduces the time and number of attempts of catheter placement and reduces the incidence of mechanical complications such as hematoma, arterial puncture, and hemothorax compared with the traditional landmark technique The OUT OF PLANE approach will allow simultaneous visualisation of the carotid artery and internal jugular vein, but it will make it difficult to control the needle tip. The IN-PLANE APPROACH will optimise needle visualisation, but it will be challenging to perform anatomical limitations such as short neck length. The ultrasound image will also display the vein unless the artery lies directly. There is a high chance of carotid injury underneath the vein. The LATERAL OBLIQUE approach combines the strengths of both previous approaches. It uses a probe alignment, and the needle is advanced from lateral to medial. This approach optimises the visualisation of the needle and the jugular vein with all its surrounding structures. The present study aims to assess and compare the performance of the lateral oblique approach with in-plane and out-of-plane approaches, which were previously not compared in terms of cannulation success and the incidence of complications. |