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CTRI Number  CTRI/2019/09/021149 [Registered on: 09/09/2019] Trial Registered Prospectively
Last Modified On: 09/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Three different way of internal jugular venous canulation with the help of ultrsound machine. 
Scientific Title of Study   Utrasound guided internal jugular venous canulation by three different transducer orientation( short axis, long axis, oblique axis): A Randomized comparative study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Swati 
Designation  Associate Professor Anaestheiology 
Affiliation   
Address  Indira Gandhi Institute of Medical Sciences.Department of Anaesthesiology and critical care, first floor.

Patna
BIHAR
800014
India 
Phone    
Fax    
Email  deepakswat@yahoo.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Swati 
Designation  Associate Professor Anaestheiology 
Affiliation   
Address  Indira Gandhi Institute of Medical Sciences.Department of Anaesthesiology and critical care, first floor.

Patna
BIHAR
800014
India 
Phone    
Fax    
Email  deepakswat@yahoo.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Swati 
Designation  Associate Professor Anaestheiology 
Affiliation   
Address  Indira Gandhi Institute of Medical Sciences.Department of Anaesthesiology and critical care, first floor.

Patna
BIHAR
800014
India 
Phone    
Fax    
Email  deepakswat@yahoo.com  
 
Source of Monetary or Material Support  
Swati, Associate Professor, Indira Gandhi Institute of Medical Sciences.Department of Anaesthesiology and critical care, first floor. 
 
Primary Sponsor  
Name  Swati 
Address  Indira Gandhi Institute of Medical Sciences. 
Type of Sponsor  Other [self] 
 
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 
Swati   Operation Theatre Complex,First Floor  Indira Gandhi Institute of Medical Sciences.
Patna
BIHAR 		 9113463130

deepakswat@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
indira gandhi institute of medical sciences ethical 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  Different imaging approaches have been described- The short –axis view approach The long –axis view approach The oblique –axis view approach   assess and compare the performance of these three approaches in term of cannulation success and incidence of complications. 
Intervention  internal jugular vein canulation.   Different imaging approaches have been described- The short –axis view approach The long –axis view approach The oblique –axis view approach  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  All patients above 18 yrs posted for IJVC in the operating room and intensive care. 
 
ExclusionCriteria 
Details  Age <18 yr
– History of previous surgical intervention at the cannulation site
– Presence of a central venous catheter during the past 72 h (in the same vein in which the present cannulation was planned)
– Infection signs or subcutaneous haematoma close to the puncture site
Analytical data suggesting severely altered haemostasis (INR >2, platelet count <50.000)

Agitated or uncooperative patient.

Recent cervical trauma with present neck immobilization
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The measure of the study was first needle pass cannulation success
 		 six months
 
 
Secondary Outcome  
Outcome  TimePoints 
Measures were number of needle passes until successful cannulation.
cannulation time measured in sec.

incidence of mechanical complications (detected during or after the procedure).
 		 18 seconds 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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 
Date of First Enrollment (India)   10/09/2019 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Troianos CA, HartmanGS, GlasKEet al.  . Special Articles: Guidelines for Performing Ultrasound Guided Vascular Cannulation: Recommendations of the American Society of Echocardiography and the Society of Cardiovascular Anesthesiologists. Anesth Analg 2012; 114: 46– 72 LampertiM, BodenhamAR, PittirutiM et al. International evidence-based recommendations on ultrasound-guided vascular access. Intensive Care Med 2012; 38: 1105– 17 PhelanM, HagertyD. The oblique view: an alternative approach for ultrasound-guided central line placement. J Emerg Med 2009; 37: 403– 8  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Internal jugular vein (IJV) is the commonest vein for central venous cannulation.It is commonly performed in operating room and critical care settings.Maximum number of times it is performed by less experienced operator.The curent evidence based recommend the use of ultrasound whenever possible.Different imaging approaches have been described. The short axis view approach,the long axis view approach, the oblique axis view approach.At majority of centres short axis view is most commonly approached view.This study was designed to assess and compare the performance of these three approaches in terms of cannulation successs and incidence of complication. 
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