FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/07/034730 [Registered on: 09/07/2021] Trial Registered Prospectively
Last Modified On: 07/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study comparing two ultrasound techniques for Radial artery cannulation in adult patients undergoing Cardiac Surgery.  
Scientific Title of Study   Prospective randomized Study of Ultrasound- Guided Out-of-Plane vs In-Plane Radial Artery Cannulation in Adult Cardiac Surgical Patients  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Achinthya Roopa Arul 
Designation  Junior Resident  
Affiliation  Kasturba Medical College  
Address  Department of Anaesthesiology Kasturba Medical College Tiger Circle Road Manipal
Tiger Circle Road Madhav Nagar Manipal Udupi- 576104
Udupi
KARNATAKA
576104
India 
Phone  9047133111  
Fax    
Email  achinthyaarul@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vijayakumara 
Designation  Associate Professor 
Affiliation  Kasturba Medical College 
Address  Department of Anaesthesiology Kasturba Medical College Tiger Circle Road Manipal
Tiger Circle Road Madhav Nagar Manipal Udupi- 576104
Udupi
KARNATAKA
576104
India 
Phone  8970213332  
Fax    
Email  vijaysd84@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vijayakumara 
Designation  Associate Professor 
Affiliation  Kasturba Medical College 
Address  Department of Anaesthesiology Kasturba Medical College Tiger Circle Road Manipal
Tiger Circle Road Madhav Nagar Manipal Udupi- 576104
Udupi
KARNATAKA
576104
India 
Phone  8970213332  
Fax    
Email  vijaysd84@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal 
 
Primary Sponsor  
Name  Kasturba Medical College Manipal 
Address  KH , manipal 
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 
Achinthya Roopa Arul  Kasturba Medical College  Department of Anaesthesiology Tiger Circle Road Madhav Nagar Manipal Udupi- 576104
Udupi
KARNATAKA 
9047133111

achinthyaarul@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical college and Kasturba 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: I00-I99||Diseases of the circulatory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  In plane ultrasound guided radial artery cannulation.   Group A-The patients posted for elective cardiac surgery requiring radial artery cannulation for monitoring will be included in this study.• In the operating room after attaching monitors and noting the base line vitals, the patient’s hand (preferably left hand) will be positioned in dorsiflexion at approximately 45 degrees and fixed over a roll in order to ensure maximum radial artery diameter. The radial artery will then be approached under strict aseptic precautions using a 20 G catheter under local anesthesia (one to two ml of plane lignocaine hydrochloride). J tip ultrasound probe will be used. The procedure will be performed in all patients by the same Anesthesiologist taking part in the study. The J probe will be placed parallel to the radial artery and cannulation will be done in the in plane view. Data such as Successful first pass radial artery cannulation, Number of redirections, Cannulation completion time, Number of attempts to cannulate the artery, Number of failed attempts and incidence of vascular complications such as hematoma, thrombosis, posterior arterial wall puncture will be recorded 
Comparator Agent  Out of plane ultrasound guided radial artery cannulation.  Group B-The patients posted for elective cardiac surgery requiring radial artery cannulation for monitoring will be included in this study.• In the operating room after attaching monitors and noting the base line vitals, the patient’s hand (preferably left hand) will be positioned in dorsiflexion at approximately 45 degrees and fixed over a roll in order to ensure maximum radial artery diameter. The radial artery will then be approached under strict aseptic precautions using a 20 G catheter under local anesthesia (one to two ml of plane lignocaine hydrochloride). J tip ultrasound probe will be used. The procedure will be performed in all patients by the same Anesthesiologist taking part in the study. The J probe will be placed perpendicular to the radial artery and cannulation will be done in the out of plane view. Data such as Successful first pass radial artery cannulation, Number of redirections, Cannulation completion time, Number of attempts to cannulate the artery, Number of failed attempts and incidence of vascular complications such as hematoma, thrombosis, posterior arterial wall puncture will be recorded 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Adult elective cardiac surgical patients
Age group of 18-70 years
All cardiac surgeries requiring radial artery cannulation
 
 
ExclusionCriteria 
Details  Patients with
Negative Allen’s test
Patients with EF less than 40%
Ulnar artery occlusion
Atherosclerotic vascular disease
Cardiogenic Shock
Morbid obesity
Raynaud’s disease
Peripheral vascular disease
Coagulation disorders
Skin infection over insertion site
Emergency cardiac surgeries
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Time taken for successful first pass radial artery cannulation
 
Time will be measured from first skin prick to successful placement of cannula into the artery indicated by typical pulsatile back flow of blood
 
 
Secondary Outcome  
Outcome  TimePoints 
Number of redirections
 
will be assessed during cannulation  
Cannulation completion time  Time will be measured from first skin prick to successful placement of cannula into the artery indicated by typical pulsatile back flow of blood
 
Number of attempts to cannulate the artery  Will be assessed during cannulation 
Number of failed attempts  Will be assessed during cannulation 
Incidence of vascular complications   will be assessed during cannulation and 15 min after and post op.  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "128"
Final Enrollment numbers achieved (India)="128" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2023 
Date of Study Completion (India) 02/11/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 02/11/2022 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
Arterial cannulation is a frequently used procedure to monitor the beat to beat arterial pressure, assessment of fluid responsiveness and can be used for frequent arterial blood sampling in the interoperative period. The radial artery is frequently chosen for its superficial location and availability of dual blood supply to the hand via the ulnar artery in the occasion of a complication. Traditionally used land mark technique has shown to require multiple attempts and frequent occurrence of bleeding and arterial spasm thereby leading to patient discomfort. With the introduction of ultrasound into medical practice and the emergence of Point of Care ultrasound, these concerns can be solved. Successful arterial cannulation can be a challenge in patients who are obese and in patients with edema, hypotension or vascular anomalies. Ultrasound guidance can be more effective than palpation for insertion of a radial artery cannula in such patients. 
Point of care ultrasound is defined as ultra-sonography brought to the patient and performed by the provider in real time. It can be used to enhance diagnostic and procedural accuracy. High frequency probes (7MHz) are preferred over lower frequency probes (<5MHz) because they provide better resolution of superficial structures in close proximity to the skin surface. The poorer penetration of high frequency probes id typically not a hinderance, because most target vascular structures intended for cannulation are <8 to 10 cm from the skin surface. 
In this study we aim to compare the rate of successful first pass radial artery cannulation in the In-Plane vs Out-of-Plane ultrasound guided techniques. 

Arora et al in 2020 compared the rate of first pass radial artery cannulation using out- of plane vs in-plane imaging. It was a prospective, randomised, observational study carried out in a tertiary care centre. They compared 84 adult patients undergoing cardiac surgery after dividing them into out-of-plane USG group (n=42) and in-plane USG group (n=42). In each approach, the number of times first pass success was achieved, number times the cannula was redirected, number of skin punctures, incidence of hematomas, and number of failed attempts were noted. The first-pass success rate was statistically significant (p=0.007) in the In-Plane USG group. A larger number of patients in the Out-of-Plane group required redirection of cannula (p= 0.002). The number of times skin needed to be punctured was also greater in the Out-of-plane group as compared to the In-Plane group (p= 0.002). The time taken for completion of cannulation and the incidence of hematomas were similar in both the groups. They concluded that the In-plane Ultrasound technique was superior in achieving a higher first pass success rate and also ensuring minimal redirections and reduced number of skin punctures. 

 Sethi et all in 2016 also did a comparison of the Short- axis out-of-plane (SA-OOP) and the long-axis in-plane (LA-IP) USG guided radial artery cannulation in adult patients. It was a prospective, randomized controlled trial. 150 patients of ASA class 1- 3 and between the age group of 18-70 were included. They were randomized into two groups of 75 each. The primary out come was successful cannulation in the first attempt. First attempt arterial cannulation was successful in 80% of patients in the SA-OOP group when compared to 82.6% in the LA-IP group. Time to successful cannulation of the artery was similar in the two groups. But time to localize the artery was higher in the LA-OOP technique (p>0.001).  Hence they concluded that the rate of first pass success and the time taken for completion of arterial cannulation was similar in both the techniques.

 Zeng et all in 2020 did a study comparing Oblique axis/In-plane (OA-IP) versus longitudinal axis/in-plane (LA-IP) approach for ultrasound guided radial artery cannulation. 60 surgical patients in the age group of 18-70 years, and falling in ASA class 1-3 were selected. They required invasive arterial line for monitoring. The primary objective was to compare the first attempt success rate in OA-IP as compared to LA-IP. They inferred thar the first attempt success rate was higher (93.3% vs 60%, p= 0.005) in the OA-IP technique when compared to the LA-IP technique. The OA-IP technique was also associated with shorter cannulation time and fewer injuries.

 Wilson Et all in 2019 did a comparison between ultrasound guided vs traditional palpation technique which was carried out by residents. 60 patients above the age of 18 requiring arterial cannulation for invasive monitoring or frequent blood sampling were recruited. The were randomized in to either groups. Their results showed that the ultrasound guided arterial cannulation group required fewer attempts as compared to the palpation technique group (96% vs 47%). They concluded that the residents were more successful and had fewer cannulation attempts with the ultrasound guided technique when compared to traditional arterial cannulation after standard intern-level ultrasound training. 

 Hansen Et all in 2014 compared Ultrasound guided dynamic needle tip positioning radial artery cannulation to traditional landmark technique. It was a randomized, patient blinded, crossover study. The patients underwent bilateral radial artery cannulation using both techniques. The primary objective was to determine the difference in needle manipulation time. Forty patients were analyzed. There was no significant difference in the needle manipulation time. In the traditional palpation technique there was use of a higher number of skin perforations, catheters and attempts at targeting the vessel. First attempt success was significantly higher in the ultrasound dynamic needle tip positioning group. They concluded that the ultrasound dynamic needle tip positioning technique significantly improves the clinically relevant parts of the procedure.

 


 
Close