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CTRI Number  CTRI/2021/07/034530 [Registered on: 02/07/2021] Trial Registered Prospectively
Last Modified On: 02/07/2021
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 traditional blind feel method of femoral artery cannulation with waveform assisted cannulation in children with heart diseases for surgery  
Scientific Title of Study   Comparison between digital palpation technique for femoral artery cannulation and transducer technique in congenital 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  PRASAD S R 
Designation  Associate Professor 
Affiliation  Sri Jayadeva institute of cardiovascular sciences 
Address  Sri Jayadeva institute of cardiovascular sciences,department of anesthesia, Bannerghatta Main Road, Phase 3, Jayanagara 9th Block, Bengaluru
Bannerghatta Main Road, Phase 3, Jayanagara 9th Block, Bengaluru
Bangalore
KARNATAKA
560069
India 
Phone  09886086232  
Fax    
Email  drprasadsr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  PRASAD S R 
Designation  Associate Professor 
Affiliation  Sri Jayadeva institute of cardiovascular sciences 
Address  Sri Jayadeva institute of cardiovascular sciences,department of anesthesia, Bannerghatta Main Road, Phase 3, Jayanagara 9th Block, Bengaluru
Bannerghatta Main Road, Phase 3, Jayanagara 9th Block, Bengaluru

KARNATAKA
560069
India 
Phone  09886086232  
Fax    
Email  drprasadsr@gmail.com  
 
Details of Contact Person
Public Query  
Name  PRASAD S R 
Designation  Associate Professor 
Affiliation  Sri Jayadeva institute of cardiovascular sciences 
Address  Sri Jayadeva institute of cardiovascular sciences,department of anesthesia, Bannerghatta Main Road, Phase 3, Jayanagara 9th Block, Bengaluru
Bannerghatta Main Road, Phase 3, Jayanagara 9th Block, Bengaluru

KARNATAKA
560069
India 
Phone  09886086232  
Fax    
Email  drprasadsr@gmail.com  
 
Source of Monetary or Material Support  
Sri Jayadeva institute of cardiovascular sciences 
 
Primary Sponsor  
Name  Sri Jayadeva Institute of Cardiovascular Sciences and Research 
Address  Bannerghatta Main Rd, Phase 3, Jayanagara 9th Block, Jayanagar, Bengaluru, Karnataka 560069 
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 
Prasad S R  Sri Jayadeva Institute of Cardiovascular Sciences and Research  first and second floor operation theater and recovery room,department of cardiac anesthesia,SJIC&R,BANGALORE
Bangalore
KARNATAKA 		 09886086232

drprasadsr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI JAYADEVA INSTITUTE ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q20-Q28||Congenital malformations of the circulatory system, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  blind palpatory technique  after palpating the artery needle is inserted to locate it ,once backflow is seen guide wire is inserted into the artey(seldinger technique) 
Intervention  Transducer technique for femoral artery cannulation  needle connected to a tranducer with continuous monitoring for the waveform is used to locate the artery once proper wzveform is confirmed guidewire is inserted over which the arterial cannula is threaded 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  10.00 Year(s)
Gender  Both 
Details  60 patients posted for congenital cardiac surgery of either sex weighing less than 10 kilograms are included 
 
ExclusionCriteria 
Details  Patients with previous attempts at arterial cannulation during the
same
• unstable patient in whom an arterial line had to be placed before the
study, randomization will be excluded. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
rate of successful cannulation at first attempt   0,6,24 HR 
 
Secondary Outcome  
Outcome  TimePoints 
Total number of attempts,

time taken to cannulate, and
Any complication related to the procedure 		 0,6,24 hrs 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   10/07/2021 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The transducer technique, a novel method for cannulation of the femoral artery, helps to increase the chances of successful guidewire insertion based on the proper waveform and also helps to differentiate between the artery and vein in cyanotic congenital heart disease. in this study, we want to compare the first pass success rate, time taken to cannulate, and the complications of this novel method to the traditional palpatory method. 
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