FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/073277 [Registered on: 03/09/2024] Trial Registered Prospectively
Last Modified On: 23/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Central line insertion]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of three views - short axis, long axis and oblique axis in use guided IJV cannulation in children aged 2-10 years 
Scientific Title of Study   USG guided IJV cannulation in children of age group 2-10 years : A comparison of three views - short axis , long axis and oblique axis in terms of insertion time and ease of insertion - A Randomised Study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aswini T 
Designation  Post graduate Student 
Affiliation  Dr SN MedicalCollege 
Address  Department of Anaesthesiology, Dr SN Medical College, Jodhpur

Jodhpur
RAJASTHAN
342003
India 
Phone  9400989488  
Fax    
Email  aswini10422@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rakesh Karnawat 
Designation  Senior professor 
Affiliation  Dr SN Medical college 
Address  Cardiothoracic OT, MDM Hospital, Jodhpur

Jodhpur
RAJASTHAN
342003
India 
Phone  9828033321  
Fax    
Email  dr.rakeshkarnawat@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Rakesh Karnawat 
Designation  Senior professor 
Affiliation  Dr SN Medical college 
Address  Cardiothoracic OT, MDM Hospital, Jodhpur

Jodhpur
RAJASTHAN
342003
India 
Phone  9828033321  
Fax    
Email  dr.rakeshkarnawat@yahoo.com  
 
Source of Monetary or Material Support  
MDM Hospital, Dr SN Medical college, Jodhpur, India, PIN code: 342003 
 
Primary Sponsor  
Name  Dr S N Medical college 
Address  Dr SN medical college, Residency Road, Sector D, Shastri Nagar, Jodhpur, India , PIN code: 342003 
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 
Dr Aswini T  Mathura Das Mathur Hospital   OT no.1, Cardiothoracic OT, Department of Anaesthesiology, MDM Hospital, Jodhpur, India, 342003
Jodhpur
RAJASTHAN 		 9400989488

aswini10422@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Dr SN Medical College, Jodhpur  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  Group Long axis  USG guided IJV Cannulation done via Long axis approach.  
Comparator Agent  Group Short Axis  USG guided IJV Cannulation done via Short axis approach. 
Comparator Agent  Oblique axis group   USG Guided IJV Cannulation done via oblique axis approach  
Intervention  USG Guided Internal Jugular Vein Cannulation  Three approaches of USG Guided Internal Jugular Vein Cannulation are compared among 3 groups in paediatric population. 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Children aged between 2 to 10 years who needed IJV cannulation 
 
ExclusionCriteria 
Details  Bleeding disorders and on anticoagulant treatment
Abnormal neck anatomy
Local infection 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mean insertion time in all three approaches of usg guided IJV cannulation  Venous access time 
 
Secondary Outcome  
Outcome  TimePoints 
Ease of insertion
Number of needle passes
Complications 		 Mean guidewire time and mean time taken for catheterisation 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   10/09/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [aswini10422@gmail.com].

  6. For how long will this data be available start date provided 05-11-2025 and end date provided 05-11-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This study compares three views ie, short , long and oblique axis of usg guided IJV cannulation among children of age group 2 - 10years in terms of insertion time as venous access time and ease of insertion along with other objectives like number of attempts and complications. 
Close