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CTRI Number  CTRI/2024/09/074305 [Registered on: 25/09/2024] Trial Registered Prospectively
Last Modified On: 23/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two techniques for cannulation of radial artery using ultrasound. Ultrasound probe perpendicular to artery(short axis-angle distance) approach versus parallel to artery (long axis in-plane)approach: A Randomized Control Trial 
Scientific Title of Study   Comparison of short axis-angle distance approach versus long axis in-plane approach of ultrasound guided radial artery cannulation: A Randomized Controlled 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  Dr. Rishi Sharma 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, New Delh 
Address  Room Number 5011, 5th Floor. Academic Block. Department Of Anaesthesiology, Pain Medicine and Critical Care. Academic Block. All India Institute of Medical Sciences, New Delhi. City- New Delhi.

South
DELHI
110029
India 
Phone  7317686155  
Fax    
Email  rshsharma90@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Chhavi Sawhney 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room Number 125, 1st Floor. Jai Prakash Narayan Trauma Centre. All India Institute of Medical Sciences, New Delhi.

South
DELHI
110029
India 
Phone  9818357051  
Fax    
Email  drchhavisawhney@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Chhavi Sawhney 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room Number 125, 1st Floor. Jai Prakash Narayan Trauma Centre. All India Institute of Medical Sciences, New Delhi.

South
DELHI
110029
India 
Phone  9818357051  
Fax    
Email  drchhavisawhney@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi. City- New Delhi. Country- India. PinCode-110029. 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi 
Address  Room Number- 5011, 5th Floor. Office- Department Of Anaesthesiology, Pain Medicine and Critical Care. All India Institute of Medical Sciences, New Delhi. City- New Delhi. Country- India. PinCode-110029 
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 Chhavi Sawhney  All India Institute of Medical Sciences, New Delhi  Room Number 5011, 5th Floor. Academic Block. Department of Anaesthesiology, Pain Medicine and Critical Care. All India Institute of Medical Sciences, New Delhi.
South
DELHI 		 9818357051

drchhavisawhney@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI  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  Ultrasound guided long axis-in plane technique(LA-IP)  n SA-AD group, a Sonosite M Turbo ultrasound machine with a linear USG probe of 8-13 MHz with small footprint will be used(Sonosite Inc, Bothell, WA,USA). The probe is placed to view the short-axis plane of the target artery and moved to place the artery in the center of the ultrasound screen. Then the probe is rotated by 90 degrees to bring the probe in the longitudinal axis of the artery. The needle is inserted and the catheter advanced under ultrasound view guidance 
Intervention  Ultrasound guided short axis- angle distance technique(SA-AD)  In SA-AD group, a Sonosite M Turbo ultrasound machine with a linear USG probe of 8-13 MHz with small footprint will be used(Sonosite Inc, Bothell, WA,USA). The probe is placed to view the short-axis plane of the target artery and moved to place the artery in the center of the ultrasound screen. Then the distance from the surface of the skin to the anterior wall of the artery is measured. Angle of 45 degrees between the needle and skin is used for puncture and the distance between the point of insertion and the central point of the probe will approximately equal to the distance from the surface of the skin to the anterior wall of the artery. Then the needle is advanced until the blood appears in the hub. The needle angle is decreased slightly while the catheter was advanced slightly. The catheter is advanced into the target artery only if blood continued to flow into the hub. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  ASA 1,2 or 3 patients posted for elective or emergency surgeries requiring radial artery cannulation. 
 
ExclusionCriteria 
Details  Patient refusal
Abnormal Modified Allen test
BMI more than 30kg per cm2
Local infection at site of cannulation
Patients with any other contraindication for radial artery cannulation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
First attempt success rate of ultrasound
guided radial artery cannulation using short axis-angle distance technique vs long axis in plane technique. 		 At Baseline. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Overall success rate
2. Total number of attempts
3. Time required for successful cannulation
4. Incidence of posterior wall puncture
5.Incidence of complications 		 Approximately 15 minutes after the induction of anesthesia 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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   Phase 3 
Date of First Enrollment (India)   05/10/2024 
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="6"
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 frequently performed procedure in patients with anticipated massive blood loss, significant hemodynamic changes or requirement of frequent blood gas sampling in perioperative period. Various arteries are being used for cannulation like radial, ulnar, femoral and dorsalis pedis. The radial artery cannulation can be done by visualizing the artery in oblique axis, long axis and transverse axis via ultrasound. Each technique has different degree of success rate. However, the optimal USG guided technique is still controversial as the results are variable. Till now there are various studies done regarding long axis approach for USG guided radial artery cannulation. There is another variation of short-axis angle distance technique which has been compared with DNTP technique. To the best of our knowledge, there are no studies that compared  short axis- angle distance with long axis technique. So, we want to compare short axis-angle distance approach with long axis-in plane approach.  
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