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CTRI Number  CTRI/2020/09/027757 [Registered on: 11/09/2020] Trial Registered Prospectively
Last Modified On: 15/12/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparison of Two Methods to Cannulate an Artery using Ultrasound  
Scientific Title of Study   Comparison of Ultrasound Guided Dynamic Needle Tip Positioning Technique and Conventional Long-Axis In-Plane Technique for Radial Arterial Cannulation in Adults Requiring Radial Arterial Cannulation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SAFIYA SHERRIN M K 
Designation  POST GRADUATE STUDENT 
Affiliation  AMALA INSTITUTE OF MEDICAL SCIENCES, THRISSUR 
Address  OASIS, VISWAS KATTACHIRA ROAD, P.O. B P ANGADI, TIRUR, MALAPPURAM, KERALA - 676102, INDIA
POST GRADUATE STUDENT, DEPARTMENT OF ANAESTHESIOLOGY, AMALA INSTITUTE OF MEDICAL SCIENCES, THRISSUR - 680555 KERALA
Thrissur
KERALA
680555
India 
Phone  9496809481  
Fax    
Email  safiyasherrin01@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR PAUL O RAPHAEL 
Designation  PROFESSOR 
Affiliation  AMALA INSTITUTE OF MEDICAL SCIENCES, THRISSUR 
Address  DEPARTMENT OF ANAESTHESIOLOGY,FIRST FLOOR, CHAVARA BLOCK, AMALA INSTITUTE OF MEDICAL SCIENCES, THRISSUR
FLAT C2 8123 SOBHA JADE SOBHA CITY PUZHAKKAL 670553 THRISSUR KERALA
Thrissur
KERALA
680555
India 
Phone  8281804916  
Fax    
Email  poloralph1965@gmail.com  
 
Details of Contact Person
Public Query
 
Name  SAFIYA SHERRIN M K 
Designation  POST GRADUATE STUDENT 
Affiliation  AMALA INSTITUTE OF MEDICAL SCIENCES, THRISSUR 
Address  OASIS, VISWAS KATTACHIRA ROAD, P.O. B P ANGADI, TIRUR, MALAPPURAM, KERALA - 676102, INDIA
POST GRADUATE STUDENT, DEPARTMENT OF ANAESTHESIOLOGY, AMALA INSTITUTE OF MEDICAL SCIENCES, THRISSUR - 680555 KERALA
Thrissur
KERALA
680555
India 
Phone  9496809481  
Fax    
Email  safiyasherrin01@gmail.com  
 
Source of Monetary or Material Support  
AMALA INSTITUTE OF MEDICAL SCIENCES, THRISSUR 
 
Primary Sponsor  
Name  AMALA INSTITUTE OF MEDICAL SCIENCES 
Address  AMALA INSTITUTE OF MEDICAL SCIENCES, AMALANAGAR, THRISSUR - 680555 
Type of Sponsor  Private 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 
SAFIYA SHERRIN M K  AMALA INSTITUTE OF MEDICAL SCIENCES  DEPARTMENT OF ANAESTHESIOLOGY,FIRST FLOOR, CHAVARA BLOCK, AMALA INSTITUTE OF MEDICAL SCIENCES, AMALANAGAR, THRISSUR - 680555, KERALA
Thrissur
KERALA 
9496809481

safiyasherrin01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AMALA INSTITUTE OF MEDICAL SCIENCES INSTITUTIONAL 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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Adults from 18 to 90 years of age
2. Adult patients undergoing General Anaesthesia/Regional Anaesthesia who require arterial cannulation 
 
ExclusionCriteria 
Details  patients with
1. age <18 years
2. age >90 years
3. negative modified Allen test
4. history radial artery cannulation in the previous 30 days
5. history of peripheral vascular disease 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Comparison of time to ultrasonographic location of radial artery and its successful cannulation  5 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
1. Ultrasonographic measurement of radial artery diameter
2. Ultrasonographic measurement of depth of radial artery from skin 
1 minute 
 
Target Sample Size   Total Sample Size="114"
Sample Size from India="114" 
Final Enrollment numbers achieved (Total)= "114"
Final Enrollment numbers achieved (India)="114" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/09/2020 
Date of Study Completion (India) 15/10/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
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
Modification(s)  
Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Comparison of Ultrasound Guided Dynamic Needle Tip Positioning Technique and Conventional Long-Axis In-Plane Technique for Radial Arterial Cannulation in Adults Requiring Radial Arterial Cannulation

INTRODUCTION
Arterial cannulation is a common invasive procedure performed in operating theatres and intensive care units. Radial artery is most commonly selected due to its superficial course, double blood supply of the hand and lower risk of complications. Multiple failed attempts at radial arterial cannulation can lead to arterial spasm and patient dissatisfaction. The use of ultrasound increases the success rates of radial arterial cannulation. Conventionally, there are two methods of radial arterial cannulation viz., Short-Axis Out-of-Plane technique and Long-Axis In-Plane technique. The short-axis ultrasound technique has the advantage of better visualization of relevant anatomy, such as abnormal vascular anatomy, nerves, and veins during arterial cannulation. The long-axis technique can provide clear visualization of the position of the needle tip as it approaches and enters the arterial lumen and thus enhance the success rate of threading of a catheter. Dynamic needle tip positioning technique is a  new technique combining the two methods. This study was done in order to compare the Dynamic Need Tip Positioning Technique with the conventional Long-Axis In-Plane method.

AIM
To compare ultrasound guided dynamic needle tip positioning technique and conventional long- axis in-plane technique for radial arterial cannulation in adults requiring radial arterial cannulation. 

OBJECTIVES 
1.To assess the success rate among ultrasound guided dynamic needle tip positioning technique in adults adults requiring radial arterial cannulation 
2.To assess the success rate among ultrasound guided long-axis, in-plane technique in adults requiring radial arterial cannulation 
3.To compare the success rates among these two groups viz. ultrasound guided dynamic needle tip positional technique and ultrasound guided long-axis, in-plane technique in adults requiring radial arterial cannulation 

HYPOTHESIS 
Ultrasound guided dynamic needle tip positioning technique is better than conventional long- axis in-plane technique for radial arterial cannulation in adults requiring radial arterial cannulation

MATERIALS AND METHODS
Hospital based observational study for patients from 18 to 90 years from Amala Institute of Medical Sciences, Thrissur to be done on 114 patients with 57  each in both Dynamic Needle Tip Positioning Technique group and Long-Axis In-Plane technique group. Radial arterial cannulation will be performed by a experienced anaesthesiologists with more than 5 years experience in ultrasound guided radial arterial cannulation under strict aseptic precautions.. Instituitional Ethical Committee approval has been obtained and informed written consent will be taken in local language from all patients and relevant data will be collected. Confidentiality of the patients will be maintained. The data obtained will be coded in Microsoft Excel sheet and statistical analysis will be done using SPSS software. 

 
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