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CTRI Number  CTRI/2024/03/064937 [Registered on: 28/03/2024] Trial Registered Prospectively
Last Modified On: 22/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cannulation procedure in intensive care unit]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two different ultrasound guided approach namely, Dynamic needle Tip Positioning and Long-axis In-plane techniques, for arterial cannulation in patients with hypotension in intensive care unit 
Scientific Title of Study   Success of Ultrasound-Guided Radial Artery Cannulation by Dynamic Needle Tip Positioning versus Long-Axis In-Plane Technique in patients with Shock: A randomised 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 Srinivasan M 
Designation  PG student  
Affiliation  The Gangaram institute for postgraduate medical education and research  
Address  Department of Critical Care Medicine, 4th floor, SSRB Building, Sir Ganga Ram hospital, Rajinder nagar, Newdelhi

New Delhi
DELHI
110060
India 
Phone    
Fax    
Email  srinivasan.m.2008@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rahul kumar 
Designation  Consultant 
Affiliation  The Gangaram institute for postgraduate medical education and research  
Address  Department of Critical Care Medicine, 4th floor, SSRB Building, SirGanga Ram hospital, Rajinder nagar, Newdelhi

New Delhi
DELHI
110060
India 
Phone    
Fax    
Email  rahul_krajput@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr srinivasan M 
Designation  PG student  
Affiliation  The Gangaram institute for postgraduate medical education and research  
Address  Department of Critical Care Medicine, 4th floor, SSRB Building, Sir Ganga Ram hospital, Rajinder nagar, Newdelhi

New Delhi
DELHI
110060
India 
Phone    
Fax    
Email  srinivasan.m.2008@gmail.com  
 
Source of Monetary or Material Support  
Sir Ganga Ram hospital, Rajinder nagar, Newdelhi- 110060 Newdelhi 
 
Primary Sponsor  
Name  Sir Gangaram Hospital  
Address  Sir Gangaram Hospital, Rajinder nagar, Newdelhi- 110060 
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 srinivasan M  Sir Ganga Ram Hospital   Department of Critical Care Medicine, 4th floor, SSRB Building,SGRH, Rajinder Nagar, Newdelhi- 110060
New Delhi
DELHI 		 9500475447

srinivasan.m.2008@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sir Ganga Ram Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I959||Hypotension, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dynamic Needle Tip Positioning  Dynamic Needle Tip Positioning is an novel approach for ultrasound guided radial artery cannulation, which uses simultaneous manipulation of ultrasound probe and needle during arterial cannulation procedure. Duration of whole procedure will take approximately 30 mins to 60 mins. 
Comparator Agent  Long-Axis In-Plane technique   Long-Axis In-Plane technique is a common technique used for arterial cannulation procedure. Duration of whole procedure will take approximately 30 mins to 60 mins. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients admitted to ICU who are in shock requiring inotropic support 
 
ExclusionCriteria 
Details  1) consent not given for radial artery cannulation
2) Presence of Arterio-venous fistula in same arm
3) local site infection
4) physical deformity at forearm or wrist 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare first-attempt success rate in ultrasound guided radial artery cannulationbetween Dynamic Needle Tip Positioning and Long Axis- In Plane techniques in patients with shock  On the day of procedure  
 
Secondary Outcome  
Outcome  TimePoints 
Comparing time variables( 1. Total procedure time,
2. Scanning time,
3. Time to arterial puncture,
4. Time to catheter insertion) and incidence of complications(1. Hematoma
2. Vasospasm
3. Posterior wall puncture
4. Thrombosis
5. Venous puncture) during procedure 		 On the day of procedure  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 
Date of First Enrollment (India)   01/05/2024 
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 Yet Recruiting 
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 whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [srinivasan.m.2008@gmail.com].

  6. For how long will this data be available start date provided 19-03-2024 and end date provided 19-03-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Invasive blood pressure monitoring is standard of care in intensive care units for patients having shock. Patients having shock who requiring vasopressors support for maintaining his/her blood pressure have significant difficulty in arterial cannulation and prone for complications during procedure even with the help of ultrasound. Radial artery is a commonly used vessel for arterial cannulation. Dynamic Needle Tip Positioning is a novel technique for ultrasound guided vascular procedures. To best of our knowledge, there are no studies done in ICU patients comparing the success rate, time for cannulation, and complications of Dynamic Needle Tip Positioning (DNTP) and Long Axis – In Plane technique( LAX-IP) techniques on radial artery cannulation in patients with shock who are potentially in need of arterial cannulation, but difficult to cannulate and prone for procedure related complications. Hence, we designed a randomized trial to investigate the better technique for ultrasound-guided radial artery cannulation, between DNTP and LAX-IP techniques in patients with shock. 
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