FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/02/017824 [Registered on: 26/02/2019] Trial Registered Prospectively
Last Modified On: 16/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing two approaches to pass a cannula in the neck veins under the ultrasound guidance 
Scientific Title of Study   Comparison of ultrasound guided internal jugular vein cannulation versus supraclavicular approach to brachiocephalic vein cannulation- a prospective randomised clinical 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 Keerthi Yogeeswara Gowda 
Designation  Post Graduate 
Affiliation  SDM medical college and hospital 
Address  Department of Anaesthesia, 2nd floor SDM medical college, Manjushree nagar, Sattur, Dharwad-580009

Dharwad
KARNATAKA
580009
India 
Phone  08362777755  
Fax    
Email  keerthiyg30@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sameer Desai 
Designation  Professor 
Affiliation  SDM medical college and hospital 
Address  Department of Anaesthesia 2nd floor SDM medical college, Manjushree nagar, Sattur, Dharwad-580009

Dharwad
KARNATAKA
580009
India 
Phone  08362777755  
Fax    
Email  sameeranaes@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Keerthi Yogeeswara Gowda 
Designation  Post Graduate 
Affiliation  SDM medical college and hospital 
Address  Department of Anaesthesia 2nd floor SDM medical college, Manjushree nagar, Sattur, Dharwad-580009

Dharwad
KARNATAKA
580009
India 
Phone  08362777755  
Fax    
Email  keerthiyg30@gmail.com  
 
Source of Monetary or Material Support  
SDM college of medical sciences and hospital, sattur, Dharwad, Karnataka, India 
 
Primary Sponsor  
Name  SDM CMSH 
Address  SDM medical college and hospital, manjushree nagar, sattur, dharwad-580009 
Type of Sponsor  Private 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 Keerthi Yogeeswara Gowda  SDM medical college and hospital  Department of Anaesthesia, 2nd floor SDM medical college and hospital, Sattur, Dharwad, Karnataka-580009
Dharwad
KARNATAKA 
08362777755

keerthiyg30@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: X||New Technology,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ultrasound guided internal jugular vein cannulation group  USG guided cannulation will be done to internal jugular vein with out of plane approach 
Comparator Agent  Ultrasound Guided supraclavicular Brachiocephalic vein cannulation group  USG guided cannlation will be done to the brachiocepalic vein with USG guidance and approach from supraclavicular area  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients requiring CVC cannulation in Operation Theatre and Intensive Care Units 
 
ExclusionCriteria 
Details  Uncooperative patients/refusal to consent.
Significant coagulopathy INR>1.5/ platelet count<50000.
History of previous surgical intervention at cannulation site.
Presence of CVC during past 72hrs in the same vein in which present cannulation is planned.
Infection/subcutaneous hematoma close to puncture site.
Cervical trauma with neck immobilization.
Emergency surgeries or emergency clinical situation in ICU
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
First attempt success rate of central venous cannulation  At the time of CVC insertion  
 
Secondary Outcome  
Outcome  TimePoints 
Cannulation time  At the time of CVC insertion  
Preocedural difficulty  At the time of CVC insertion  
Complication rate  time of CVC insertion to 24 hour after procedure 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   28/02/2019 
Date of Study Completion (India) 29/10/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Title: Comparison Of Ultrasound Guided Internal Jugular Vein Cannulation Versus Supraclavicular Approach To Brachiocephalic Vein Cannulation- A Prospective Single Blind Randomised Clinical Study

 

Background and objectives: Cannulation of veins and arteries is an important aspect of patient care for the administration of fluids, medications and for monitoring purposes. Internal jugular vein (IJV) cannulation is the most commonly studied site for central vein cannulation in adults. The Brachiocephalic vein (BCV) has become a preferred option for central venous cannulation in paediatrics, but its use in adults remains limited and very few studies compare the BCV to other cannulation sites. Recently, a retrospective study was done on USG guided BCV cannulation which suggested that BCV cannulation is a safe and viable alternative to IJV.  The objective of this study is to compare the USG guided out of plane approach to IJV cannulation with in-plane USG guided supraclavicular approach to BCV cannulation in adults for the success rate, first attempt success rate, procedural ease and also to record the incidence of complications related to either approach.

Methodology: In this study, the 110 patients recruited were randomly allocated into two groups of 55 patients each. The patients demographic details like age, gender, indication for cannulation, ventilation status and PEEP applied were noted. In group IJV, right internal jugular vein cannulation was performed using ultrasound guidance out of plane approach and in group BCV, right brachiocephalic vein cannulation was performed using ultrasound guidance for supraclavicular in-plane approach. Success rate of cannulation, number of attempts to cannulate the veins, ease of guidewire and catheter insertion, cannulation time and any associated complications were recorded.

Result: The demographic details were similar between the two groups. Successful cannulation was 100% in BCV group and 98.5% in IJV group, which was statistically insignificant. The first attempt success rate was 81.81% and 76.3% in BCV and IJV group respectively. IJV was collapsed in 14.5% cases and BCV was collapsed in 0.9% cases, which was significant. The needle visualisation was better with BCV group (80% in IJV group and 94.54% in BCV group), which was statistically significant. The number of redirections of needle was more in IJV group. The CVC cannulation time and complication rates were similar between the groups.

Conclusion: Ultrasound guided supraclavicular in-plane BCV cannulation is a good alternative to USG guided out of plane IJV cannulation, by having a good calibre and better needle visualisation in the BCV group. Overall success rate, first attempt success rate, time duration for cannulation and complication rate remain similar between the two groups. 

 

 

 
Close