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CTRI Number  CTRI/2022/01/039374 [Registered on: 13/01/2022] Trial Registered Prospectively
Last Modified On: 13/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARATIVE STUDY OF THE SUCCESSFUL CANNULATION OF THE INTERNAL JUGULAR VEIN USING ULTRASOUND IN TWO APPROACHES 
Scientific Title of Study   ULTRASOUND GUIDED LONG AXIS VERSUS SHORT AXIS APPROACH FOR COMPARISON OF FIRST PASS SUCCESS RATE OF INTERNAL JUGULAR VEIN CANNULATION: A PROSPECTIVE RANDOMISED 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  Dr SOWMYA L N 
Designation  PG Resident 
Affiliation  MS Ramaiah Medical College 
Address  Department of Aneasthesiology , 2nd floor Ramaiah Medical College Hospital ,New BEL Road Bangalore KARNATAKA 560054 INDIA

Bangalore
KARNATAKA
560054
India 
Phone  8197279370  
Fax    
Email  sowmyaln94@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr THEJESWINI 
Designation  ASSISTANT PROFESSOR 
Affiliation  MS Ramaiah Medical College 
Address  Department of Aneasthesiology , 2nd floor Ramaiah Medical College Hospital ,New BEL Road Bangalore KARNATAKA 560054 INDIA

Bangalore
KARNATAKA
560054
India 
Phone  9110493783  
Fax    
Email  thejummc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr SOWMYA L N 
Designation  PG Resident 
Affiliation  MS Ramaiah Medical College 
Address  Department of Aneasthesiology , 2nd floor Ramaiah Medical College Hospital ,New BEL Road Bangalore KARNATAKA 560054 INDIA

Bangalore
KARNATAKA
560054
India 
Phone  8197279370  
Fax    
Email  sowmyaln94@gmail.com  
 
Source of Monetary or Material Support  
MS Ramaiah Medical College MSRIT post New Bel Road Bangalore-560054 
 
Primary Sponsor  
Name  MS Ramaiah Medical College 
Address  MSRIT Post New BEL Road Bangalore-560054 
Type of Sponsor  Private medical college 
 
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 
Dr SOWMYA L N  Ramaiah Medical College Hospital  Department of Anaesthesiology 2nd floor Ramaiah Medical College Hospital New BEL Road Bangalore -560054
Bangalore
KARNATAKA 		 8197279370

sowmyaln94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee MS Ramaiah Medical College  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  not applicable  not applicable 
Intervention  Ultrasound guided IJV cannulation  Ultrasound usage in IJV cannulation makes the technique easier with less complication rate. IJV cannulation using ultrasound can be done via Short axis or Long axis. Each technique has its own advantage and disadvantage. So in this study we intend to compare the first pass success rate using both techniques. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  patients who need Central Venous Cannulation 
 
ExclusionCriteria 
Details  1)History of previous surgical intervention at the cannulation site
2)Presence of CVC during the past 72 hr( in the same vein in which the present cannulation was planned)
3)Infection or subcutaneous haematoma close to the puncture site
4)Recent cervical trauma with present neck immobilization
5)Analytical data suggesting severely altered haemostasis (INR >2, Platelet Count <50,000)
6)Subcutaneous emphysema with cervical extension
7)Agitated or Uncooperative patient
8)Thrombosed vein
9)Morbid obesity
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
i)compare the first pass success rate
ii)time taken to insert the guidewire
iii)Complications
 		 during the procedure(ijv cannulation) and post procedure
 
 
Secondary Outcome  
Outcome  TimePoints 
complications:
•Carotid artery puncture
•Puncture site bleeding
•Local cervical haematoma
•Hemothorax
•Pneumothorax
•Catheter misplacement
 		 during IJV cannulation and post IJV cannulation 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   15/01/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Cannulation of the internal jugular vein(IJV) is a procedure commonly performed by anaesthetists . Ultrasound, facilitates direct visualisation of the IJV, its dimensions, orientation, and surrounding structures resulting in improved first pass success rates, reduced number of needle passes and less inadvertent injury to surrounding structures . The National Institute for Clinical Excellence (NICE) published guidelines supporting the routine use of Ultrasound guidance for IJV cannulation .In addition, USG(Ultrasonography) can facilitate CVC placement in special clinical situations in which landmark techniques based on palpation of the arterial pulse are challenging or impossible. USG imaging of the IJV may be oriented along either short axis(SA) (cross sectional view) or long axis(LA) (longitudinal view)5. In this study we are comparing the first pass success rate between the two axis (short vs. long) of the Ultrasound view for cannulation of the IJV.

 
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