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CTRI Number  CTRI/2024/07/069783 [Registered on: 01/07/2024] Trial Registered Prospectively
Last Modified On: 28/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare ultrasound guided central venous catheterization through external jugular vein route to the ultrasound guided central venous catheterization through internal jugular vein route among individuals aged between 18 to 65 years. 
Scientific Title of Study   Comparison of ultrasound guided central venous catheterization through external jugular vein route to the ultrasound guided central venous catheterization through internal jugular vein route, a randomized trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dasari Praveen Kumar 
Designation  Resident 
Affiliation  Indira Gandhi Medical College, Shimla 
Address  Department of Anesthesia, Indira Gandhi Medical College, Shimla

Shimla
HIMACHAL PRADESH
171001
India 
Phone  7981247143  
Fax    
Email  d.praveen505@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Usha Kumari Chaudhary  
Designation  Assistant Professor  
Affiliation  Indira Gandhi Medical College, Shimla 
Address  Department of Anesthesia, Indira Gandhi Medical College, Shimla

Shimla
HIMACHAL PRADESH
171001
India 
Phone  9459301813  
Fax    
Email  chaudhary.ushaarvind@gmail.com  
 
Details of Contact Person
Public Query  
Name  Usha Kumari Chaudhary  
Designation  Assistant Professor  
Affiliation  Indira Gandhi Medical College, Shimla 
Address  Department of Anesthesia, Indira Gandhi Medical College, Shimla

Shimla
HIMACHAL PRADESH
171001
India 
Phone  9459301813  
Fax    
Email  chaudhary.ushaarvind@gmail.com  
 
Source of Monetary or Material Support  
Indira Gandhi Medical College, Shimla, Himachal Pradesh ,Pincode -171001 
 
Primary Sponsor  
Name  Indira Gandhi Medical College 
Address  Indira Gandhi Medical College, Lakkar Bazaar Road, Shimla, Himachal Pradesh, India, Pincode -171001 
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 Praveen Kumar  Indira Gandhi Medical College and Hospital  General ICU, Indira Gandhi Medical College, Shimla
Shimla
HIMACHAL PRADESH 		 7981247143

sailaja5641@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Indira Gandhi Medical College, Shimla  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I959||Hypotension, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  USG guided central venous catheterization in ICU through external jugular vein  Central venous catheterization in chronically ill patients in ICU will be done ultrasonographically through external jugular vein. 
Comparator Agent  USG guided central venous catheterization in ICU through internal jugular vein  Central venous catheterization in chronically ill patients in ICU will be done ultrasonographically through internal jugular vein.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA III, IV, V
Chronic ill patients in ICU of age between 18 years to 65 years  
 
ExclusionCriteria 
Details  Refusal to participate in study
Patients with deranged coagulation profile
Head and neck burns patient  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of ultrasound guided central venous catheterization through external jugular vein route to the ultrasound guided central venous catheterization through internal jugular vein route, a randomized trial.  Comparison of ultrasound guided central venous catheterization through external jugular vein route to the ultrasound guided central venous catheterization through internal jugular vein route in chronic ill patients in ICU and the respective outcomes will be assessed at one week. 
 
Secondary Outcome  
Outcome  TimePoints 
To study & compare the complications associated with external jugular vein versus internal jugular vein approach & to determine position of tip of cannula via chest X-ray.  Comparison of ultrasound guided central venous catheterization through external jugular vein route to the ultrasound guided central venous catheterization through internal jugular vein route & the outcomes will be assessed at one week. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   09/07/2024 
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="1"
Days="10" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - NO
Brief Summary   Comparison of ultrasound guided central venous catheterization through external jugular vein route to the ultrasound guided central venous catheterization through internal jugular vein route, a randomized trial. 
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