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CTRI Number  CTRI/2024/07/070866 [Registered on: 18/07/2024] Trial Registered Prospectively
Last Modified On: 28/05/2026
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   Clinical trial to compare arterial cannulation by Direct waveform assistance against ultrasound guided arterial cannulation 
Scientific Title of Study   Comparison of Arterial Cannulation by Direct Waveform Assistance (DiWA) Against Ultrasound Guided Arterial Cannulation: A Randomized Non-Inferiority Clinical 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 Lekha B Kallappagoudra 
Designation  Junior Resident 
Affiliation  Post Graduate Institute of Medical education and Research 
Address  Dept of anaestheia and intensive care, Post Graduate Institute of Medical education and Research, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7406100857  
Fax    
Email  lekhak0125@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Narender Kaloria 
Designation  Assistant Professor 
Affiliation  PGIMER 
Address  Dept of anaesthesia and intensive care, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  8872495145  
Fax    
Email  naren.keli@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Lekha B Kallappagoudra 
Designation  Junior Resident 
Affiliation  Post Graduate Institute of Medical education and Research 
Address  Dept of anaestheia and intensive care, Post Graduate Institute of Medical education and Research, Chandigarh


CHANDIGARH
160012
India 
Phone  7406100857  
Fax    
Email  lekhak0125@gmail.com  
 
Source of Monetary or Material Support  
Post graduate institue of medical education and research, Chandigarh, India 160012 
 
Primary Sponsor  
Name  Post graduate institue of medical education and research 
Address  Post graduate institue of medical education and research, Sector 12 Chandigarh 160012 
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 
Dr Lekha  Post Graduate Institute of Medical education and Research  Operation Theatres under the department of anaesthesia and intensive care, Post Graduate Institute of Medical education and Research, Chandigarh, India 160012
Chandigarh
CHANDIGARH 		 7406100857

lekhak0125@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Post Graduate Institute of Medical education and Research, Chandigarh Institutional Ethics Committee (Intramural)  Approved 
Post Graduate Institute of Medical education and Research, Chandigarh Institutional Ethics Committee (Intramural)  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 
Intervention  Direct Waveform guided arterial cannulation  A 20-gauge (G) arterial cannula with stylet in situ will be attached to the transducer through a pressure monitoring line to form a DiWA assembly. The transducer is then attached to the anaesthesia workstation monitor and the transducer will be zeroed at the level of the heart. The arterial cannula will be inserted in the radial artery at an angle of 45 degrees. Once the cannula with stylet enters inside the artery, the arterial waveform appears on the monitor. Then, the angle of the cannula is reduced and the stylet will be slightly withdrawn (1-2mm), if the waveform is still present it confirms the placement of the cannula inside the artery. Now, simultaneously the stylet will be removed while advancing the cannula in the artery. 
Comparator Agent  Ultrasound guided arterial cannulation  Arterial cannulation will be done with the help of ultrasound (GE SG Cart/Ultrasound Trolley Ref 5720863) and a 5-10 MHz USG probe will be prepared by covering it with a sterile camera cover. Sterile jelly will be used to fill the gap of cover and footprint of the USG probe. Place the prepared linear probe on the skin proximal to the anticipated needle insertion point of the non-dominant hand. After obtaining an optimal cross-sectional image of the radial artery in the distal forearm, position the artery in the centre of the screen using a short axis view. Hold the cannulation device by the dominant hand of anaesthesiologist orienting the needle bevel facing up. Aim the needle at about a 30- to 45-degree angle into the skin towards the midpoint of the probe. Fan the ultrasound probe to identify the needle tip. The needle appears hyperechoic (appears as a white dot on the ultrasound screen in the transverse view). Once the position of the needle tip is confirmed inside the artery, then move the USG probe 5 mm proximal till the needle tip disappears. The angle of insertion of the needle should be decreased and further advanced till it again appears inside the artery. If the needle does not appear inside the artery then insertion will be adjusted accordingly. (Dynamic needle positioning). Now, simultaneously the stylet will be removed while advancing the cannula in the artery. Keep the cannula stationary at this point and attach the pressure monitoring line. After confirming the waveform, fix the cannula with adhesive tape.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult patients aged 18 to 65 years, either gender, American Society of Anaesthesiologists (ASA) physical status 1-3 requiring arterial cannulation under general anaesthesia for elective or emergency surgeries will be included in the study. 
 
ExclusionCriteria 
Details  Refusal to participate, surgery under regional anaesthesia, negative modified Allen’s test for collaterals, patients with a diagnosis of peripheral vascular disease, surgery at the radial artery site, coagulation disorders, hemodynamically unstable patients, obese patients BMI more than 35, burns at arterial puncture site, local site infection. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluate if DiWA is non-inferior to ultrasound-guided arterial cannulation in terms of first-attempt success rate.  baseline and at 24hours 
 
Secondary Outcome  
Outcome  TimePoints 
Time to be required for successful cannulation  in seconds/ minutes 
Number of redirections needed for arterial cannulation.  1-3 
Number of attempts for successful cannulation  1-3 
Overall success or failure rates   Successful/ failure 
Rate of complications at arterial puncture site such as hematoma formation, vasospasm following arterial cannulation.  between 0 to 100% 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/07/2024 
Date of Study Completion (India) 30/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/04/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ethic_01_couches@icloud.com].

  6. For how long will this data be available start date provided 01-12-2026 and end date provided 06-03-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Arterial cannulation is a common procedure done in operating theatres and intensive care units for continuous blood pressure recording as well as frequent blood sampling. It is usually done by palpatory methods as well as ultrasound-guided. Ultrasound has various advantages as compared to palpatory methods such as real-time guidance, fewer chances of failure or formation of hepatoma/ vasospasm. The disadvantage of ultrasound is its cost and availability. To overcome this disadvantage, a new technique using Direct waveform assistance is being proposed in which an arterial cannula is attached to a pressure transducer through a pressure monitoring line and the pressure waveform appears on the monitor once the cannula is inside the artery. This technique will be used for the first time in this study. It has given promising results in a few pilot cases. Hence, this is planned to compare arterial cannulation guided by direct waveform assistance (DiWA) with ultrasound in patients requiring arterial cannulation under general anaesthesia. 
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