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CTRI Number  CTRI/2022/07/043694 [Registered on: 05/07/2022] Trial Registered Prospectively
Last Modified On: 26/02/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Comparative 
Study Design  Other 
Public Title of Study   ease of Subclavian central venous line insertion by Ultrasound guidance versus landmark guided method: a prospective observational study” 
Scientific Title of Study   “Ultrasound- versus landmark-guided subclavian vein catheterization: a prospective observational study” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sujit Kshirsagar 
Designation  Assistant Professor 
Affiliation  B.J. Medical College and sassoon general hospitals, Pune 
Address  Department of Anaesthesiology, B.J.Government Medical College and Sassoon General Hospital, Pune-01

Pune
MAHARASHTRA
411001
India 
Phone  09022177719  
Fax    
Email  bjsujit@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sujit Kshirsagar 
Designation  Assistant Professor 
Affiliation  B.J. Medical College and sassoon general hospitals, Pune 
Address  Department of Anaesthesiology, B.J.Government Medical College and Sassoon General Hospital, Pune

Pune
MAHARASHTRA
411001
India 
Phone  09022177719  
Fax    
Email  bjsujit@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sujit Kshirsagar 
Designation  Assistant Professor 
Affiliation  B.J. Medical College and sassoon general hospitals, Pune 
Address  Department of Anaesthesiology, B.J.Government Medical College and Sassoon General Hospital, Pune

Pune
MAHARASHTRA
411001
India 
Phone  09022177719  
Fax    
Email  bjsujit@gmail.com  
 
Source of Monetary or Material Support  
B.J. Government Medical College and Sassoon General Hospital, Pune 
 
Primary Sponsor  
Name  Dr Sujit Kshirsagar 
Address  Jai Prakash Narayan Road, Railway Station Rd, near Pune Railway Station, Maharashtra- 411001 
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 
Dr Sujit J Kshirsagar  B. J. Govt. MEDICAL COLLEGE and SASSOON GENERAL HOSPITALS, PUNE   Trauma ICU , Trauma care centre, BJGMC AND SGH, Pune
Pune
MAHARASHTRA 		 09022177719

bjsujit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, B. J. Govt. MEDICAL COLLEGE, SASSOON GENERAL HOSPITALS, PUNE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T149||Unspecified injury,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients will be selected from ICU for SCV cannulation after assessment by senior faculty. Critically ill patients from 18 to 65 years of age, of either gender will be selected. Indications for CVC insertion will be following: hemodynamic monitoring, treatments with vasopressors or any drug likely to induce phlebitis, haemodialysis, requirement of multiple drug infusions simultaneously.  
 
ExclusionCriteria 
Details  Life-threatening conditions requiring an emergency CVC positioning will be excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary aim is to evaluate the ease of subclavian central venous cannulation in critically ill patients between two techniques.  immediately measured time for insertion of central venous line 
 
Secondary Outcome  
Outcome  TimePoints 
to evaluate the number of attempts, cannulation failure, and mechanical complications which if develops  5 minutes after the procedure 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/07/2022 
Date of Study Completion (India) 15/10/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
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 - Clinical Study Report

  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 - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 20-06-2022 and end date provided 20-06-2027?
    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  

    The subclavian vein (SCV) is a common site of percutaneous access for central vein cannulation in intensive care. This site offers several advantages, including a lower incidence of thrombosis and central venous catheter (CVC)-related sepsis, with better patient comfort and easier nursing care.1-3 SCV is an alternative to internal jugular vein (IJV) when this is difficult to locate, as in hypovolemic or obese patients.4,5 SCV cannulation has the advantage of fixed landmarks but may be associated with potentially severe complications, e.g., pneumothorax or hemothorax, likely related to limited operator experience.6,7

The role of ultrasonography (USG) for IJV catheterization has been accepted as the standard of care after the recommendations by National Institute for Health and Clinical Excellence (NICE) in 2002, but the same guidelines stated that there was insufficient evidence to support the use of USG for SCV catheterization. A Cochrane systematic review published in 2015 concluded that “two-dimensional USG offers small advantages in terms of safety and quality in comparison with an anatomical landmark technique for either subclavian or femoral vein cannulation”.8 On the other hand, in recent years, several trials have shown a reduction in complications and an improvement in first-pass success when USG were used.9-12

The goals of present observational study are to compare, in two groups of adult patients, the effectiveness and safety of SCV cannulation with USG or landmark-guided technique.

 
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