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CTRI Number  CTRI/2015/04/005728 [Registered on: 29/04/2015] Trial Registered Retrospectively
Last Modified On: 20/04/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   When we use marked introducer needle versus unmarked introducer needle for central vein cannulation which one is better with ultrasound-guidance. 
Scientific Title of Study   Comparison between marked versus unmarked introducer needle in real-time ultrasound-guided central vein cannulation-A prospective randomized study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ratender K Singh 
Designation  Associate Professor 
Affiliation  Sanjay Gandhi Post Graduate Institute of Medical Sciences 
Address  Department of Critical Care Medicine. Sanjay Gandhi Post Graduate Institute of Medical Sciences

Lucknow
UTTAR PRADESH
226014
India 
Phone  913211255676  
Fax    
Email  ratender@sgpgi.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Ratender K Singh 
Designation  Associate Professor 
Affiliation  SGPGI 
Address  Department of Critical Care Medicine. SGPGIMS

Lucknow
UTTAR PRADESH
226014
India 
Phone  913211255676  
Fax    
Email  ratender@sgpgi.ac.in  
 
Details of Contact Person
Public Query  
Name  Ratender K Singh 
Designation  Associate Professor 
Affiliation  SGPGI 
Address  Department of Critical Care Medicine. SGPGIMS

Lucknow
UTTAR PRADESH
226014
India 
Phone  913211255676  
Fax    
Email  ratender@sgpgi.ac.in  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Sanjay Gandhi Post graduate Institute of Medical Sciences 
Address  Rai barelly road.Lucknow 60014 
Type of Sponsor  Research institution 
 
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 
Ratender Singh  Critical care medicine department intensive care unit 1st floor  Sanjay Gandhi Post graduate institute of Medical Sciences Raibareilly road.Lko. 226014
Lucknow
UTTAR PRADESH 		 9415189124

ratender@sgpgi.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sanjay Gandhi PostGraduate Institue  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  critically ill patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  marked and unmarked needle  independent observer 
Intervention  ultra sound guided central venous cannulation  Ultrasonographic guidance will be performed in real time using a Sonosite 180plus (Bothell, WA) with an 8-MHz linear transducer by a single operator with more than 5yrs experience in central venous cannulation and 1 yr. experience in handling USG machine and probes. Operator will hold the probe in a transverse plane to the IJV to be canulated in the diversion of sternocleidomastoid muscle at the level of cricoid cartilage.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  At the time of admission to CCM ICU adult (>18yrs) patients who require ultrasound guided central venous catheterization will be included in the study. 
 
ExclusionCriteria 
Details  • Pediatric patients
• Patient without consent.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Dates of Birth or day of the Week 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the effectiveness of marked versus unmarked introducer needle along with real time ultrasound guidance in central venous cannulation of critically ill patient.  During real time ultrasound guided central venous cannulation in critically ill patients. 
 
Secondary Outcome  
Outcome  TimePoints 
To study the rate of complications of both the techniques.  NA 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   20/02/2013 
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 Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Central venous cannulation is a part of essential care in critically ill patients. Ultrasound guided cannulation is now the recommended practise in central venous cannulation. But introducer needle tip is not well visible during real time ultrasound. This leads to insertion difficulties, incorrect estimation and increase in complications like arterial puncture and pneumothorax. This study was designed to evaluate whether real-time ultrasound-guided central vein cannulation with a marked introducer needle is superior to the unmarked introducer needle.

 
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