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CTRI Number  CTRI/2022/11/047785 [Registered on: 30/11/2022] Trial Registered Prospectively
Last Modified On: 29/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Blind versus Ultrasound Guided Methods to attain Radial Artery Cannula Access 
Scientific Title of Study   Comparative Study of Radial Artery Cannulation by Conventional Palpatory Method versus USG Guided Technique in Adult Patients Undergoing Elective Surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aman Shukla 
Designation  PG Resident 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  C-9/9491, Vasant Kunj, New Delhi

South West
DELHI
110070
India 
Phone  9717483727  
Fax    
Email  amanxshukla@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr G Usha 
Designation  Professor and Consultant 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesiology, VMMC and Safdarjung Hospital, Ansari Nagar East, New Delhi

South
DELHI
110029
India 
Phone  8447795934  
Fax    
Email  doctorgusha@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr G Usha 
Designation  Professor and Consultant 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesiology, VMMC and Safdarjung Hospital, Ansari Nagar East, New Delhi


DELHI
110029
India 
Phone  8447795934  
Fax    
Email  doctorgusha@hotmail.com  
 
Source of Monetary or Material Support  
Vardhman Mahavir Medical College, New Delhi 
 
Primary Sponsor  
Name  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi, Delhi 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 
Aman Shukla  Vardhman Mahavir Medical College and Safdarjung Hospital  Department of Anaesthesiology, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi, Delhi 110029
South
DELHI 
9717483727

amanxshukla@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vardhman Mahavir Medical College and Safdarjung Hospital Institutional 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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Radial Artery Cannulation  The trial will be done to compare the two methods of achieving radial artery cannulation- palpatory vs the USG guided technique. The cannulation procedure will be done only after the patient posted for major elective surgery is induced under anaesthesia. Non-dominant hand will be chosen, local anaesthesia will be applied at the site of radial artery access. The equipment will be setup and all the cannulations will be done with a 20G catheter of the same make under strict aseptic precautions. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. ASA grade I and II patients.
2. Age group of 18 to 65 years of either gender.
3. Patients posted for elective major surgery. 
 
ExclusionCriteria 
Details  1. Coagulation defects/anticoagulant therapy
2. Obesity defined by body mass index > 30kg/m2
3. Patients in shock
4. Patients who have received radial artery cannulation within previous 30 days
5. Local lesions/ burns/ orthopaedic defects/ grafts
6. Negative Modified Allen’s test
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare first attempt success rates of conventional palpatory method and ultrasound guided technique for radial artery cannulation in adult patients undergoing elective major surgery.  Just after anaesthetic induction of patient and before the beginning of surgical procedure. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare overall success rates of conventional palpatory method and USG guided technique for radial artery cannulation in adult patients undergoing elective major surgery.  Just after anaesthetic induction of patient and before the beginning of surgical procedure. 
To compare time taken for successful cannulation by conventional palpatory method and ultrasound guided technique for radial artery cannulation in adult patients undergoing elective major surgery.  Just after anaesthetic induction of patient and before the beginning of surgical procedure. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/12/2022 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet 
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 procedure which is very often put into use in acute and critical care settings. It is an invasive means to measure the blood pressure and mean arterial pressure more accurately as well as to provide beat to beat assessment of hemodynamic status in critical situations compared to the non-invasive means. In addition, it is very useful for repeated sampling of ABG in critical care settings.
Continuous invasive blood pressure monitoring is of extreme importance for monitoring patients who are in a critical condition or those who are undergoing a major surgery. Although non-invasive blood pressure measurement is generally safe, it can lead to rare but severe complications. One possibility is that of compartment syndrome, which can develop after prolonged periods of frequent cycling and mostly observed in situations such as trauma to the limb, hypovolemic shock or impaired distal limb perfusion.
Arterial cannulation needs technical expertise for placement and management. Despite drawbacks such as high risk, invasive procedure, associated complications, and high cost involved, it is still the accepted reference standard for blood pressure monitoring. Arterial cannulation is indicated if there is need for continuous, real-time blood pressure monitoring, anticipated pharmacological or mechanical cardiovascular manipulation, need for repeated blood sampling, failure of indirect arterial blood pressure management or requirement of supplementary diagnostic information from arterial waveform.
For invasive blood pressure monitoring, various arteries can be used including the radial, brachial, axillary, femoral and dorsalis pedis arteries. The most common access for real time blood pressure monitoring is gained via radial artery cannulation. This is so because the radial artery runs a superficial course, has fewer complications, and the hand has a dual blood supply. Before cannulating the radial artery, assessment of collateral blood flow by the modified Allen’s test is mandatory. Though Allen’s test is the only tool available for assessment of efficiency of collateral circulation in hand, unfortunately, predictive value of this test has been found to be poor and prognostic value of this test in detecting adequate collateral circulation is unconfirmed.
 Radial artery cannulation by palpatory (conventional) method is achieved mainly by three techniques: direct arterial puncture, guidewire assisted cannulation (Seldinger technique), and the transfixion withdrawal method.
In recent years, ultrasonography-guided radial artery cannulation has become a common method to access the radial artery. Ultrasound guided technique offers a direct view of the vessel lumen followed by guiding the cannula directly inside the lumen avoiding damage either to the vessel or adjacent structures. There are studies that have also shown that ultrasonography-guided radial artery cannulation improves the first attempt success rate for cannula insertion and also consumes less time as compared to the conventional palpatory method. However, there is a learning curve for achieving expertise in the ultrasound guided technique.
On review of literature for studies, we found that there is a paucity of research materials with respect to comparing the conventional and ultrasound guided techniques of arterial cannulation particularly in Indian population. We are undertaking a study comparing conventional palpatory method of radial artery cannulation with that of ultrasound technique for radial arterial cannulation in Indian adults posted for elective major surgical procedures.
 
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