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CTRI Number  CTRI/2022/04/042244 [Registered on: 28/04/2022] Trial Registered Prospectively
Last Modified On: 24/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia
Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare success and complication rate of inserting catheter in the large central vein (Subclavian) using either ultrasound or landmark guided approach in patient receiving mechanical ventilation. 
Scientific Title of Study   Comparison of success and complication rate during Subclavian vein cannulation using ultrasound guided long-axis in-plane technique and anatomical landmark guided technique in mechanically ventilated patients: A Prospective Randomized Open Label Study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sadik Mohammed 
Designation  Associate professor 
Affiliation  All India Institute of Medical sciences, Jodhpur 
Address  3rd floor, OPD block, AIIMS hospital, Basani phase 2, Jodhpur, Rajasthan.

Jodhpur
RAJASTHAN
342005
India 
Phone  9414849733  
Fax  0291-2740741  
Email  drmsadik@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sadik Mohammed 
Designation  Associate professor 
Affiliation  All India Institute of Medical sciences, Jodhpur 
Address  3rd floor, OPD block, AIIMS hospital, Basani phase 2, Jodhpur, Rajasthan.

Jodhpur
RAJASTHAN
342005
India 
Phone  9414849733  
Fax  0291-2740741  
Email  drmsadik@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Praveen BK 
Designation  PG Student 
Affiliation  ALL India Institute of Medical Sciences 
Address  3rd floor, OPD block, AIIMS hospital, Basani phase 2, Jodhpur, Rajasthan.

Jodhpur
RAJASTHAN
342005
India 
Phone  7022642652  
Fax    
Email  praveenbk93@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical sciences, Basani phase 2, Jodhpur, Rajasthan, 342005 
 
Primary Sponsor  
Name  All India Institute of Medical sciences 
Address  Basani phase 2, Jodhpur, Rajasthan. 342005 
Type of Sponsor  Research institution and hospital 
 
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 
Praveen BK  All India Institute of Medical sciences  Department of Anesthesiology and critical care, 3rd floor, OPD block, AIIMS hospital, Basani phase 2, Jodhpur, Rajasthan. 342005
Jodhpur
RAJASTHAN 
7022642652
0291-2740741
praveenbk93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS, JODHPUR, Institutional Ethics 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  Anatomical landmark guided SCV cannulation  Placement of SCV catheter guided by anatomical landmark perioperatively or during ICU stay.  
Intervention  Real time Ultrasound guided SCV cannulation  Placement of SCV catheter guided by ultrasound perioperatively or during ICU stay. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  1) Patient aged 18years old or older.
2) Belonging to American Society of Anesthesiologist Physical Status 1-3.
3) Belonging to either sex.
4) Either scheduled for elective surgery requiring CVC or admitted in the ICU and receiving mechanical ventilation. 
 
ExclusionCriteria 
Details  1) Patient having infection at the access site.
2) Patients with coagulopathy or on anticoagulation therapy.
3) Subclavian vein could not be visualised or appear thrombosed during initial screening. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the first attempt success rate of SCV cannulation using the two techniques   During Procedure 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the overall success rate of SCV cannulation using the two technique
To compare the time required for successful SCV cannulation using the two technique
To compare the complications of SCV cannulation using the two technique  
Periprocedural 
 
Target Sample Size   Total Sample Size="214"
Sample Size from India="214" 
Final Enrollment numbers achieved (Total)= "234"
Final Enrollment numbers achieved (India)="234" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/05/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/10/2023 
Estimated Duration of Trial   Years="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet 
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 whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 (Others) -  On personal request by mail to drmsadik@gmail.com

  6. For how long will this data be available start date provided 01-01-2024 and end date provided 31-12-2028?
    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   A central venous catheter (CVC) is an indwelling vascular catheter with a tip that lies within the proximal third of the superior vena cava, the right atrium, or the inferior vena cava. Central venous catheterisation was first performed in 1929 by Werner Frossman using a ureteric catheter inserted through the antecubital vein and advanced into the right ventricle under fluoroscopy. Later on Sven-Ivar Seldinger in 1953, introduced a technique that facilitates catheter placement into lumens and body cavities. Since then, placement of a CVC using the Seldinger technique revolutionized medicine by allowing safe and reliable venous access.
Recently, the use of ultrasound (US) guidance and improvements in catheter care have further reduced complication rates.
The CVC can be inserted through a peripheral vein or a proximal central vein, most commonly the internal jugular vein (IJV), subclavian vein (SCV), or femoral vein. Among the patients admitted in intensive care unit (ICU), the SCV is a common site of CVC placement because of several associated advantages, including a lower incidence of thrombosis and catheter related blood stream infection (CRBSI), with better patient comfort and easier nursing care. It is analternative to IJV in hypovolemic or obese patients. 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.
The “global use of ultrasound” is a newer concept that highlights the role of US for central
venous access not only for planning but also for identifying early and late complications.
Based upon the available literature, the multidisciplinary consensus guidelines from various
societies recommended the use of real-time US guidance for IJV cannulation however, the literature is insufficient to recommend the use of US during SCV cannulation. A few
randomized controlled and observational studies are conducted to assess the role of real time
US guidance during SCV cannulation.
 
Hence, we are planning a randomized controlled open label study to evaluate the role of real
time US guidance for SCV cannulation. We hypothesize that the use of real time US guidance
during SCV cannulation would provide higher success rate and lower complication rate as
compared to anatomical landmark guided technique in mechanically ventilated critically ill patients
 
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