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CTRI Number  CTRI/2023/08/056691 [Registered on: 21/08/2023] Trial Registered Prospectively
Last Modified On: 19/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparing ultrasound-guided dynamic needle tip positioning technique to conventional palpation technique for Radial arterial cannulation 
Scientific Title of Study   Ultrasound-guided dynamic needle tip positioning technique versus conventional palpation technique for radial arterial cannulation-a randomized 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  Dr Suneela Channabasappa Biradar 
Designation  PG Resident Anaesthesiology 
Affiliation  M S Ramaiah Medical College 
Address  Department of Anaesthesiology M S Ramaiah Medical College Bangalore New BEL Road MSRIT Post Bangalore Bangalore KARNATAKA 560054 India

Bangalore
KARNATAKA
560054
India 
Phone  9108185406  
Fax    
Email  sunilbiradar36@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Yatish B 
Designation  Professor 
Affiliation  M S Ramaiah Medical College 
Address  Department of Anaesthesiology M S Ramaiah Medical College Bangalore New BEL Road MSRIT Post Bangalore Bangalore KARNATAKA 560054 India

Bangalore
KARNATAKA
560054
India 
Phone  9886197658  
Fax    
Email  yatishseeni@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Yatish B 
Designation  Professor 
Affiliation  M S Ramaiah Medical College 
Address  Department of Anaesthesiology M S Ramaiah Medical College Bangalore New BEL Road MSRIT Post Bangalore Bangalore KARNATAKA 560054 India

Bangalore
KARNATAKA
560054
India 
Phone  9886197658  
Fax    
Email  yatishseeni@yahoo.co.in  
 
Source of Monetary or Material Support  
MS Ramaiah Medical College MSRIT Post New BEL Road Bangalore 560054 
 
Primary Sponsor  
Name  MS Ramaiah Medical College 
Address  New BEL Road MSRIT Post MSR Nagar Bangalore 560054 
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 Suneela Channabasappa Biradar  MS Ramaiah Medical College Hospital  Department Of Anaesthesiology Second Floor MS Ramaiah Medical College Hospital New BEL Road Bangalore Bangalore Karnataka
Bangalore
KARNATAKA 
9108185406

sunilbiradar36@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MS Ramaiah Medical College 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, (2) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Radial Arterial Cannulation  Ultrasound Guided Radial arterial cannulation Using Dynamic Needle Tip Positioning Technique 
Comparator Agent  Radial Arterial Cannulation  Radial Arterial Cannulation Using Conventional Palpatory Method 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients undergoing an elective surgical procedure that required the use of invasive arterial pressure monitoring aged between 18 to 60 years. 
 
ExclusionCriteria 
Details  History of forearm surgery
Skin infection at the puncture site
Abnormal modified Allen test
Coagulation dysfunction
Pregnant female
Had radial artery cannulation in last 30 days 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the first pass success rate between Dynamic needle tip positioning technique & conventional palpation technique for radial
artery cannulation 
successfully obtaining an arterial waveform after one
pass through the skin with the needle within 5 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the cannulation time & number of skin punctures between Dynamic needle tip positioning technique and conventional palpation technique for Radial arterial cannulation  Overall success of obtaining an arterial waveform within 5 minutes & number of skin punctures 
 
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)   30/08/2023 
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="2"
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 - NO
Brief Summary  

Arterial cannulation is a common invasive procedure performed in the emergency room, ICU and operating room indicated especially in major operation and critical patients to monitor beat to beat hemodynamic changes. Radial artery is most commonly used due to its superficial course, dual blood supply of the hand, and low risk of complications.

Radial artery cannulation was traditionally performed by palpation of radial artery pulsation. USG guided techniques have been widely used in various vascular cannulations because of its visual characteristics and higher success rate of cannulation compared with traditional palpation.

Dynamic needle tip positioning  is a new modified ultrasound technique that is shown to result in greater peripheral venous catheterization success rate when compared to long-axis in-plane view in a phantom model.Use of this method for radial arterial cannulation was described in a case report by Goh et al. The dynamic needle tip positioning method combines the advantages of short-axis out of plane and long-axis in-plane ultrasound techniques.

Very few studies have been done comparing this new modification of ultrasound technique with traditional palpation technique. Therefore, we propose to conduct this study and hypothesize that this new technique would result in significant increase in first pass success rate of radial artery cannulation.

 
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