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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  
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 
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  
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  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 
Details   
 
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.

 
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