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CTRI Number  CTRI/2020/10/028248 [Registered on: 06/10/2020] Trial Registered Prospectively
Last Modified On: 11/03/2024
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 arterial insertion in two different artery of lower limb in adult patients undergoing surgery under general anaesthesia  
Scientific Title of Study   Comparison of ultrasound guided dorsalis pedis artery versus posterior tibial artery cannulation in adult patients undergoing surgery under general anaesthesia: A Randomised control study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashutosh Kaushal 
Designation  Assistant Professor 
Affiliation  AIIMS,Rishikesh 
Address  Department of Anaesthesiology, AIIMS,Rishikesh, India Dehradun UTTARANCHAL 246201 India

Dehradun
UTTARANCHAL
249201
India 
Phone    
Fax    
Email  drashutosh.kaushal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ashutosh Kaushal 
Designation  Assistant Professor 
Affiliation  AIIMS,Rishikesh 
Address  Department of Anaesthesiology, AIIMS,Rishikesh, India Dehradun UTTARANCHAL 246201 India

Dehradun
UTTARANCHAL
249201
India 
Phone    
Fax    
Email  drashutosh.kaushal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ashutosh Kaushal 
Designation  Assistant Professor 
Affiliation  AIIMS,Rishikesh 
Address  Department of Anaesthesiology, AIIMS,Rishikesh, India Dehradun UTTARANCHAL 246201 India

Dehradun
UTTARANCHAL
249201
India 
Phone    
Fax    
Email  drashutosh.kaushal@gmail.com  
 
Source of Monetary or Material Support  
Aiims Rishikesh 
 
Primary Sponsor  
Name  AiimsRishikesh 
Address  All India Institute of Medical Sciences Rishikesh 
Type of Sponsor  Research institution and hospital 
 
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 
Ashutosh Kaushal  All India Institute of Medical Sciences,Rishikesh  virbhadra marg, Rishikesh,Dehradun,249203 Dehradun UTTARANCHAL
Dehradun
UTTARANCHAL 		 9599156154

drashutosh.kaushal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC,AIIMS,RISHIKESH  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 dorsalis pedis cannulation.  After viewing the artery in cross section, the transducer will be rotated 90°, keeping the image in the centre of the ultrasound screen to identify the artery in its long axis (in plane approach). When the artery appeared as a tubular anechoic structure, BD 20G arterial cannula (Becton, Dickinson and Company, New Jersey, USA) will be inserted with bevel-up orientation at about 30 to 45° to the skin and parallel to the transducer directly under the centre of the transducer. The needle and artery will both be visualized entirely with in plane approach of ultrasound imaging. After confirming the needle tip within the lumen and the arterial blood flashback in the needle hub, the angle of the needle will be lowered and gently advanced slightly more distally under ultrasound guidance. After arterial blood flashback, the stylet will be slightly removed and the arterial catheter will be advanced further for complete cannulation. Cross section diameter of artery will be measured in both pre and post procedure in horizontal position. The assessment time will be defined as“time between start of screening of artery to skin puncture by needle”. Cannulation time will be defined as “time between the initial needle penetration through the skin to successful cannulation of artery.” Successful arterial cannulation will be measured by “removal of the metal needle/stylet and continuation of a flash of arterial blood.” Attempts will be quantified as the number of needle advances through a new skin puncture . Failure will be defined as “failure of successful cannulation after three attempts.”  
Intervention  Ultrasound Guided Posterial popleteal artery insertion.  After viewing the artery in cross section, the transducer will be rotated 90°, keeping the image in the centre of the ultrasound screen to identify the artery in its long axis (in plane approach). When the artery appeared as a tubular anechoic structure, BD 20G arterial cannula (Becton, Dickinson and Company, New Jersey, USA) will be inserted with bevel-up orientation at about 30 to 45° to the skin and parallel to the transducer directly under the centre of the transducer. The needle and artery will both be visualized entirely with in plane approach of ultrasound imaging. After confirming the needle tip within the lumen and the arterial blood flashback in the needle hub, the angle of the needle will be lowered and gently advanced slightly more distally under ultrasound guidance. After arterial blood flashback, the stylet will be slightly removed and the arterial catheter will be advanced further for complete cannulation. Cross section diameter of artery will be measured in both pre and post procedure in horizontal position. The assessment time will be defined as“time between start of screening of artery to skin puncture by needle”. Cannulation time will be defined as “time between the initial needle penetration through the skin to successful cannulation of artery.” Successful arterial cannulation will be measured by “removal of the metal needle/stylet and continuation of a flash of arterial blood.” Attempts will be quantified as the number of needle advances through a new skin puncture . Failure will be defined as “failure of successful cannulation after three attempts.”  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Age between 18 – 65 years (both gender)
2.American Society of Anaesthesiologist Physical Status I-IV
3.Patients undergoing surgeries under general anaesthesia requiring arterial cannulation.
 
 
ExclusionCriteria 
Details  1.Patient refusal to consent.
2.Patient with absence of arterial pulsation.
3.Skin erosions near the insertion site.
4.Patient undergoing surgery on lower limbs.
5.Patients with peripheral vascular disease.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Proportion of First attempt success in each arm.
 		 At the time of arterial cannulation 
 
Secondary Outcome  
Outcome  TimePoints 
The average time taken for assessment in each arm.
Proportion of Number of attempts to cannulate the artery in each arm.
Proportion of Success Rate in each arm.
Incidence of Complications, if any in each arm.
 		 At the time of arterial cannulation, After arterial cannulation 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/10/2020 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Intraarterial cannulation is an imperative component of anesthesia and intensive care units. It

is commonly instituted for beat-to-beat blood pressure monitoring, frequent arterial blood

gas analysis and guiding fluid therapy. The advantages of ultrasound guided artery

cannulation include: real-time visualization of landmarks, improved pre-procedure

planning, reduction in complications, less time spent at the bedside, and improved

first-attempt success rates that is evident in number of studies. With improved success rate

of cannulation by ultrasound technique, it has become a standard of care. Foot arteries

are selected as an alternative to the radial artery cannulation in cases of

unsuccessful cannulation of radial artery due to anatomical abnormalities/ tortuosity’s,

low pulse volume, in head and neck surgeries, if the upper limb is burnt or injured or

in surgical procedures involving arms. Studies comparing dorsalis pedis artery and

posterior tibial artery cannulation using ultrasound guidance is lacking.

This study is proposed to compare the success rate of ultrasound guided posterior tibial

artery cannulation versus dorsalis pedis artery cannulation in patients undergoing surgery

under general anaesthesia.

 
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