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CTRI Number  CTRI/2024/05/068099 [Registered on: 30/05/2024] Trial Registered Prospectively
Last Modified On: 29/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Comparative study of First attempt success rate of Ultrasound guided and Palpatory method of Posterior Tibial artery cannulation . 
Scientific Title of Study   A Randomised Comparative study of First attempt success rate of Ultrasound guided and Conventional palpatory technique of Posterior Tibial artery cannulation in adult patients  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jyoti Kumari  
Designation  Postgraduate student  
Affiliation  ABVIMS and Dr RML Hospital  
Address  Department of Anesthesia ABVIMS & Dr RML Hospital New Delhi

Central
DELHI
110001
India 
Phone  9958125363  
Fax    
Email  kumari210197@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Namita Arora 
Designation  Professor  
Affiliation  ABVIMS and Dr RML Hospital  
Address  Department of Anaesthesia ABVIMS and Dr RML HOSPITAL NEW DELHI

Central
DELHI
110001
India 
Phone  9868219619  
Fax    
Email  drnamitaarora@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jyoti Kumari 
Designation  Post graduate Resident 
Affiliation  ABVIMS and Dr RML Hospital  
Address  Department of Anaesthesia ABVIMS and Dr RML Hospital NEW DELHI

Central
DELHI
110001
India 
Phone  9958125363  
Fax    
Email  kumari210197@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia,Third floor, PGI building ,ABVIMS and Dr. RML Hospital, Baba kharak Singh Road, CP, New Delhi- 110001 
 
Primary Sponsor  
Name  ABVIMS and Dr RML Hospital  
Address  Department of Anaesthesia ABVIMS and Dr RML Hospital , Baba kharak Singh marg, CP, New Delhi 110001 
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 
Dr JYOTI KUMARI   ABVIMS and Dr RML Hospital   Department of Anesthesia, Third floor Room 301, PGIMER Building , New Delhi-110001
Central
DELHI 		 9958125363

kumari210197@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. RML Hospital New Delhi Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  First attempt success rate  To compare first attempt success rate of ultrasound guided and conventional palpatory technique of posterior tibial artery cannulation in adult patients based on a. First attempt success rate: successful cannulation following first time skin puncture. b. Number of Attempts c. Total Cannulation time : sum of time taken from initial skin penetration by the needle till successful cannulation of artery which is appearance of arterial blood flash on removal of guide wire. d. Incidence of complications arterial spasms, thrombosis or tissue necrosis  
Intervention  Posterior Tibial Artery Cannulation by Ultrasound guided technique and Palpation technique   After attaching all standard ASA monitors, with all aseptic precautions, a 20 G arterial cannula will be used to percutaneously puncture the posterior tibial artery using modified Seldinger technique either by a. Palpation technique: by palpating in the groove between the medial malleolus and tendon of Achilles. b. Ultrasound guided technique: a high frequency linear transducer probe will be used to visualise artery. The posterior tibial artery is first visualised in short axis view then long axis view, needle insertion by in- plane technique within a duration of 10 minutes . 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. American Society of Anaesthesiology I-IV patients
2. All eligible patients  
 
ExclusionCriteria 
Details  Patients with erosions , injuries or scar marks at the site of cannulation
Body mass index more than 35 kilograms per metre square
Patients with peripheral vascular disease
Patients in shock
Patients with coagulopathies
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
First attempt success rate: successful cannulation following first time skin puncture   A successful cannulation will be defined by appearance of arterial blood flash through the cannula after withdrawal of guide wire and time taken is noted 
 
Secondary Outcome  
Outcome  TimePoints 
Number of attempts   Number of times skin is freshly punctured  
Total Cannulation time  Total time in minutes taken from initial skin puncture with the needle till successful cannulation of arteries that is appearance of arterial blood flash on removal of guide wire at baseline 
Any complications   Arterial spasms, haematoma following skin puncture  
 
Target Sample Size   Total Sample Size="272"
Sample Size from India="272" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   15/06/2024 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response (Others) -  NIL

  4. For what types of analyses will this data be available?
    Response (Others) -  NIL

  5. By what mechanism will data be made available?
    Response (Others) -  NIL

  6. For how long will this data be available start date provided 18-02-2024 and end date provided 18-02-2024?
    Response (Others) -  NIL

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is a Randomised Comparative Study of First attempt success rate of ultrasound guided and conventional palpatory technique of posterior tibial artery cannulation in adult patients.
Venue of Study: ABVIMS and Dr. RML Hospital, New Delhi- 110001
Sample size is 272 ( 136 each group)
The primary objective is to compare first attempt success of ultrasound guided and conventional palpatory technique of posterior tibial artery cannulation in adult patients 
The secondary objectives are :
a. Number of attempts 
b. Total Cannulation time
c. Incidence of complications arterial spasms, thrombosis or tissue necrosis 
 
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