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CTRI Number  CTRI/2018/12/016762 [Registered on: 21/12/2018] Trial Registered Prospectively
Last Modified On: 21/12/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective Analytical Study 
Study Design  Single Arm Study 
Public Title of Study   Influence of expertise of anaesthesiologist in various domains with respect to securing a catheter/tube in large vein using ultrasound 
Scientific Title of Study   Influence of operator characteristics and different approaches on successful ultrasound guided central venous cannulation in paediatric patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nandini Dave 
Designation  Additional Professor 
Affiliation  Seth GSMC and KEM Hospital Mumbai 
Address  Paediatric OT, Seth GSMC and KEM Hospital, Acharya Donde Marg, Parel, Mumbai, Maharashtra 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  9819392094  
Fax    
Email  nandinidave@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nandini Dave 
Designation  Additional Professor 
Affiliation  Seth GSMC and KEM Hospital Mumbai 
Address  Paediatric OT, Seth GSMC and KEM Hospital, Acharya Donde Marg, Parel, Mumbai, Maharashtra 400012


MAHARASHTRA
400012
India 
Phone  9819392094  
Fax    
Email  nandinidave@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nandini Dave 
Designation  Additional Professor 
Affiliation  Seth GSMC and KEM Hospital Mumbai 
Address  Paediatric OT, Seth GSMC and KEM Hospital, Acharya Donde Marg, Parel, Mumbai, Maharashtra 400012


MAHARASHTRA
400012
India 
Phone  9819392094  
Fax    
Email  nandinidave@gmail.com  
 
Source of Monetary or Material Support  
Self funded by the Department of Paediatric Anaesthesia, 3rd floor Old Building, Seth GSMC and KEM Hospital, Acharya Donde Marg, Parel, Mumbai, Maharashtra 400012  
 
Primary Sponsor  
Name  Department of Paediatric Anaesthesia 
Address  Seth GSMC and KEM Hospital, Acharya Donde Marg, Parel, Mumbai, Maharashtra 400012  
Type of Sponsor  Government 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 
Swarup Ray  Seth GSMC and KEM Hospital Mumbai  Paediatric OT, 3rd floor, Old Building Seth GSMC and KEM Hospital, Acharya Donde Marg, Parel, Mumbai, Maharashtra 400012
Mumbai
MAHARASHTRA 
9886100987

swarupswarupswarup@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) II KEM Hospital Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R688||Other general symptoms and signs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Paediatric patients less than 12 years requiring central venous catheterisation under general anaesthesia 
 
ExclusionCriteria 
Details  Children with any contraindication to central line placement such as coagulopathy, platelet count <50,000/mm3, on antiplatelet or anticoagulant medications 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare operator characteristics including anaesthesiologist experience, experience in paediatric anaesthesia, experience in paediatric central lines, experience in ultrasound guided lines and experience in a particular approach to central venous cannulation with success rate of line placement  After guidewire insertion 
 
Secondary Outcome  
Outcome  TimePoints 
To compare various operator characteristics with respect to number of attempts, complications and time required for central venous cannulation  After guidewire insertion 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2019 
Date of Study Completion (India) 04/09/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 04/09/2019 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Central venous cannulation remains a mainstay procedure used in the treatment of critically ill patients as well as patients coming for major surgeries. Ultrasound guidance has improved the safety level of this procedure. However, successful line placement would vary between different operators with different experience as well as different approaches. The exact nature of these differences is unclear and yet to be defined in the paediatric population. Understanding the nature of these relationships can help define practices which would further enhance the safety and success rate of this procedure.
So the aim of this study would be to investigate the various operator related factors to different approaches of central venous cannulation in children below 12 years.
We want to include children below 12 years requiring central venous catheterisation under general anaesthesia. Children with any contraindication to central line placement such as coagulopathy, platelet count <50,000/mm3, on antiplatelet or anticoagulant medications would be excluded.
It will be a prospective analytical study for a period of 1 year. Written informed consent will be obtained prior to the procedure from the parents. Different operators (with more than 3 years experience in anaesthesiology and who have placed more than 50 central lines) would perform central venous cannulation. Selection of operators and approach would be non-randomised and depend on the consultant anaesthesiologist and operator themselves.The primary outcome measure would be to compare operator characteristics like anaesthesiologist experience, experience in paediatric anaesthesia, experience in paediatric central lines, experience in ultrasound guided lines and experience in a particular approach to central venous cannulation with respect to success rate of line placement, number of attempts, time taken for line placement and complications. Secondary outcomes would be to compare different approaches to central venous cannulation with respect to success rate, number of attempts, complications, time for cannulation as well as to compare success rate, number of attempts, complications, time for cannulation with respect to patient age, weight, as well as anaesthetic technique. The SPSS 24.0. software will used for statistical analysis of data of this study. Chi-square test will be used to test the association of different study variables and t-test will used to compare the means. Significance level will set at ≤0.05.
 
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