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CTRI Number  CTRI/2022/12/048432 [Registered on: 23/12/2022] Trial Registered Prospectively
Last Modified On: 27/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of ultrasound guided approaches for inserting cannula in radial artery 
Scientific Title of Study   Comparison Of Longitudinal Axis in Plane Approach Vs Oblique Axis in Plane Approach for Ultrasound Guided Radial Artery Cannulation- A Randomized Controlled Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Christopher Dass 
Designation  Assistant Professor 
Affiliation  AIIMS New Delhi 
Address  5 th floor AIIMS Teaching Block Department of Anaesthesia Pain Medicine Critical Care
5 th floor AIIMS Teaching Block Department of Anaesthesia Pain Medicine Critical Care
South
DELHI
110029
India 
Phone  9560177416  
Fax    
Email  christopherdass25@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Christopher Dass 
Designation  Assistant Professor 
Affiliation  AIIMS New Delhi 
Address  5 th floor AIIMS Teaching Block Department of Anaesthesia Pain Medicine Critical Care
5 th floor AIIMS Teaching Block Department of Anaesthesia Pain Medicine Critical Care
South
DELHI
110029
India 
Phone  9560177416  
Fax    
Email  christopherdass25@gmail.com  
 
Details of Contact Person
Public Query  
Name  Christopher Dass 
Designation  Assistant Professor 
Affiliation  AIIMS New Delhi 
Address  5 th floor AIIMS Teaching Block Department of Anaesthesia Pain Medicine Critical Care
5 th floor AIIMS Teaching Block Department of Anaesthesia Pain Medicine Critical Care
South
DELHI
110029
India 
Phone  9560177416  
Fax    
Email  christopherdass25@gmail.com  
 
Source of Monetary or Material Support  
AIIMS New Delhi 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  5 th floor Anaesthesia department AIIMS Ansari Nagar New Delhi 
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 
Christopher Dass  AIIMS New Delhi  Opearation Theatres AIIMS New Delhi
South
DELHI 		 9560177416

christopherdass25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS New Delhi Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N185||Chronic kidney disease, stage 5, (2) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (3) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  longitudinal axis In plane approach for radial artery cannulation  radial artery will be cannulated via longitudinal axis in plane approach using ultrasound 
Intervention  Oblique Axis In plane approach for radial artery cannulation  radial artery will be cannulated via oblique axis in plane approach using ultrasound 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients in whom radial artery cannulation is indicated of
Either Sex
Age 20-50 years
BMI 35 or less
 
 
ExclusionCriteria 
Details  a. Patients with positive modified Allen test
b. Patient with coagulopathy
c. Peripheral arterial disease
d. Infection or burn at the site of infection.
e. Patient in shock
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the first attempt success rate of radial artery cannulation using USG guided LA-IP approach and OA-IP approach  first attempt  
 
Secondary Outcome  
Outcome  TimePoints 
• To compare the time required in arterial localization.
• To compare cannulation time using two approaches.
• To compare the complications that occurred during cannulation using these two approaches
 		 arterial localization time
cannulation time
 
 
Target Sample Size   Total Sample Size="192"
Sample Size from India="192" 
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)   02/01/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   not published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Radial artery cannulation is required in many surgical procedures. Use of ultrasound make it easy in simple and anatomically difficult situations. Usually short axis out of plane and longitudinal axis in plane approaches are used to insert radial artery cannula. A new approach oblique axis in plane has been recently described in a randomized clinical trial. In this approach first ultrasound is put longitudinally then rotated 15 degree to see artery as an elliptical anechoic shadow. We hypothesize that there will be higher first attempt success rate by using this approach and shorter cannulation time as compared to longitudinal axis in plane approach. There will also be a shorter cannulation time.  
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