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CTRI Number  CTRI/2025/08/092880 [Registered on: 12/08/2025] Trial Registered Prospectively
Last Modified On: 11/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison Between Two Approaches Of Ultrasound Guided Radial Artery Cannulation. 
Scientific Title of Study   COMPARISON BETWEEN THE ULTRASOUND GUIDED DYNAMIC NEEDLE TIP POSITIONING USING SHORT-AXIS, OUT-OF-PLANE APPROACH AND LONGITUDINAL OBLIQUE AXIS APPROACH FOR RADIAL ARTERY CANNULATION IN PATIENTS UNDERGOING EMERGENCY EXPLORATORY LAPROTOMY WITH PERIOPERATIVE HYPOTENSION - A PROSPECTIVE RANDOMIZED NON-INFERIORITY TRIAL  
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 Geetanjali T Chilkoti 
Designation  Professor 
Affiliation  UCMS & GTB Hospital 
Address  Dept of Anaesthesiology and Critical Care UCMS and GTB Hospital Delhi
Dept of Anaesthesiology and Critical Care UCMS and GTB Hospital Delhi
East
DELHI
110095
India 
Phone  09711210772  
Fax    
Email  geetnjalidr@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Geetanjali T Chilkoti 
Designation  Professor 
Affiliation  UCMS & GTB Hospital 
Address  Dept of Anaesthesiology and Critical Care UCMS and GTB Hospital Delhi
Dept of Anaesthesiology and Critical Care UCMS and GTB Hospital Delhi
East
DELHI
110095
India 
Phone  09711210772  
Fax    
Email  geetnjalidr@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Vishakhi Kamra 
Designation  PG student 
Affiliation  UCMS & GTB Hospital 
Address  Dept of Anaesthesiology and Critical Care UCMS and GTB Hospital Delhi
Dept of Anaesthesiology and Critical Care UCMS and GTB Hospital Delhi
East
DELHI
110095
India 
Phone  7988768139  
Fax    
Email  kamravishakhi@gmail.com  
 
Source of Monetary or Material Support  
Main ICU, Second floor, University college of medical science and GTB Hospital, Dilshad Garden 110095, India  
 
Primary Sponsor  
Name  UCMS and GTB Hospital  
Address  Dept of Anaesthesiology and Critical Care UCMS and GTB Hospital Delhi 110095 
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 Vishakhi Kamra  UCMS & GTB Hospital  Main ICU second floor Department of Anesthesiology and critical care OT block university college of medical science and GTB hospital Dilshad garden
East
DELHI 		 07988768139

kamravishakhi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethics Committe human research  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 
Comparator Agent  Radial artery cannulation using longitudinal oblique axis  In group O artery identification will be like group D Longitudinal axis view will be obtained and the probe rotated at an angle of 15°to 20° lateral clockwise on the right hand or counter clockwise on the left hand The elliptical artery will be identified and probe rocking done to maximize the cross sectional area Arterial cannula will be inserted on the midpoint of short axis of the US probe at an angle of 30° to 45° into the skin under real time guidance and confirmation will be done like group D 
Intervention  radial artery cannulation using short axis out of plane with dynamic needle tip positioning  In group D, for the SA-OP using DNTP technique, the RA will be identified using the SAOP approach. An arterial cannula will be inserted at a 30° to 45° angle in the centre of the probe until the ultrasound image displays the needle tip as a hyperechoic dot. After that the US probe will be moved proximally along the arm until the image no longer showed the needle tip. Keeping the probe in place the cannula will be moved further towards the RA until the needle tip will be visible on the USs image once again. This step-by-step procedure will be repeated until the tip of the needle is visible in the middle of the lumen of the RA. Then, the needle will be removed and the catheter will be advanced inside the arterial lumen, the transducer tubing will be attached, and the arterial pressure waveform will be recorded. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Consenting adult patients of either sex aged 18-60 yrs undergoing emergency exploratory laparotomy with perioperative hypotension and on inotropes. 
 
ExclusionCriteria 
Details  Negative Modified Allens test
Anatomic variation of the radial artery
Peripheral arterial disease
Infection or burn at the site of insertion
History of coagulation disorders
History of forearm surgery
Radial artery cannulation in the past 30 days
BMI more than
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Time for successful cannulation   interval from the start of US probe manipulation to the successful placement of the catheter within the vessel lumen achieving an endpoint of arterial waveform on the monitor. 
 
Secondary Outcome  
Outcome  TimePoints 
First attempt success rate number of attempts failure rate
Imaging time
Overall success rates
Incidence of complications
Operator satisfaction rates
 		 Imaging time will be defined as the duration from the initial manipulation of the US probe to the moment the target RA appeared centred on the screen


 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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 2/ Phase 3 
Date of First Enrollment (India)   28/08/2025 
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="5"
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  data will only be available if asked by the requisite journal at the time of publication

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The two main techniques for Ultrasound guided radial artery RA cannulation are Longaxis,in plane LA IP and short-axis out plane SA OP technique Longitudinal oblique axis LOA is a modified LA IP technique which provides wider visualized area as well direct needle visualization. LOA and Dynamic needle tip positioning DNTP have come up as an alternative techniques for LA IP and SA OP respectively  SA OP with DNTP has been established as the desirable technique however LOA has emerged as the promising technique in terms of higher success rate We hypothesize LOA to be non inferior to SA OP with DNTP  On literature search these techniques have not been evaluated in patients with difficult cannulation eg obesity and hypotension All routine standard monitors will be attached The hypotension will be managed by vasopressors and inotropes as per the protocol  In all patients Modified Allens test will be performed with the arm placed on a flat armrest in moderate dorsiflexion 30 degree to 45 degree which will be achieved by placing a towel under the dorsal aspect of wrist  Patients will be randomized into group D and O In group D DNTP using SA OP will be used and in group O LOA approach will be used  Various parameters like Time for successful cannulation Imaging time first attempt success rate number of attempts  failure rate  overall success rate complications and operator satisfaction rate will be recorded

 
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