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CTRI Number  CTRI/2022/07/044094 [Registered on: 18/07/2022] Trial Registered Prospectively
Last Modified On: 30/06/2022
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 two different approaches of ultrasound-guided techniques for insertion of catheter inside artery of hand in elderly patients: A prospective study 
Scientific Title of Study   Comparison of ultrasound-guided dynamic needle tip positioning versus longitudinal axis in-plane technique for radial artery cannulation in elderly: A prospective randomized controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhishek Nagarajappa 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no. 5, fourth floor portacabin, In front of lift number 12, adjacent to AB4 ward, Wardblock, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  8587970180  
Fax    
Email  abhishek.nagarajappa@outlook.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhishek Nagarajappa 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no. 5, fourth floor portacabin, In front of lift number 12, adjacent to AB4 ward, Wardblock, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  8587970180  
Fax    
Email  abhishek.nagarajappa@outlook.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhishek Nagarajappa 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no. 5, fourth floor portacabin, In front of lift number 12, adjacent to AB4 ward, Wardblock, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  8587970180  
Fax    
Email  abhishek.nagarajappa@outlook.com  
 
Source of Monetary or Material Support  
AIIMS New Delhi 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 
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 Abhishek Nagarajappa  Operation Theater of AIIMS  8th Floor, 1st floor ortho complex, Main Building and 7th Floor, CDER Building
South
DELHI 
8587970180

abhishek.nagarajappa@outlook.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institute Ethics Committee  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  Ultrasound guided Dynamic needle tip positioning technique of radial artery cannulation  After identifying the artery in a SAX view a 20 G arterial cannula will be inserted in an out-of-plane (OOP) approach keeping the artery in the centre of the screen. The needle will be advanced in the midline till a hyperechoic dot will be visible in the centre of the screen. Then only the probe will be moved proximally without moving the needle till the hyperechoic dot just disappears. Next, keeping the probe fixed at that place, needle will then be advanced towards the radial artery till hyperechoic dot reappears. Once the needle punctures the radial artery, the probe will be moved further proximally leaving the needle tip in the centre of the radial artery. After confirmation that sufficient length of the needle tip remains in the radial artery, the outer catheter will be pushed to the end, and the stylet will be removed. 
Comparator Agent  Ultrasound guided Longitudinal axis in-plane technique of radial artery cannulation  After identifying the artery in the LAX a 20G arterial cannula will be inserted keeping the longitudinal section of artery in view. The needle will be advanced in an in-plane (IP) approach visualising the whole path of the needle including the needle tip till the radial artery will be punctured. Once the radial artery is punctured the outer catheter will be pushed to the end and the stylet will be removed. 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1 Patients undergoing general anaesthesia and requiring arterial cannulation
2 ASA status I, II or III
3 Age 65 years or older
 
 
ExclusionCriteria 
Details  1 Patient’s refusal to participate
2 Hemodynamically unstable
3 Allen’s test positive
4 Hematoma or local site infection
5 Known peripheral vascular disease or Raynaud’s phenomenon
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
First attempt success rate between the two techniques  At the time of arterial cannulation 
 
Secondary Outcome  
Outcome  TimePoints 
1. No of attempts and redirections
2. Time to successful cannulation
3. Posterior wall puncture
4. Hematoma formation 
At the time of Arterial cannulation 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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)   22/07/2022 
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="2"
Months="0"
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  

Arterial cannulation in one of the frequently performed procedure under anaesthesia in cases with expected massive blood loss, large hemodynamic changes and frequent blood gas sampling in perioperative period (1). Radial artery is preferred over other arteries as the hand has dual arterial supply from radial and ulnar artery (2).

Ultrasound (US) can be used for guiding arterial cannulation in difficult cases. US guided radial artery cannulation has shown to have a higher first attempt success rate compared to palpation method (3–6). Two approaches have been used for US guided arterial cannulation: short axis out-of-plane (SAX-OOP) and long axis in-plane (LAIP) approach. In SAX-OOP approach, US image of the shaft or the tip of the cannula will appear as hyperechoic dot; whereas in LAIP approach whole path of needle including the tip can be visualized. LAIP technique has been shown to be better than palpatory method of arterial cannulation (5). Moreover, previous randomized controlled trials (RCT) comparing these two US guided techniques demonstrated higher first attempt success rate with LAIP technique for radial artery cannulation (7,8).

However, in order to overcome the problems of SAX-OOP approach, recently a modified short axis technique using dynamic needle tip positioning (DNTP) was introduced. It has shown to have higher first attempt success rate and lesser posterior arterial wall puncture compared to palpation method (5) and SAX-OOP method (6).

A previous study comparing DNTP with LAIP demonstrated higher first attempt success rate with DNTP technique in adult patients for cardiac surgery. However, cannulating the radial artery in elderly population is difficult due to age related vascular changes and tortuosity of the vessels (9) and no studies have compared these two techniques in elderly patients.

Therefore, we planned to conduct a study to compare the US guided DNTP versus LAIP technique in elderly patients. We hypothesise DNTP technique has higher first attempt success rate in elderly compared to LAIP technique for radial artery cannulation.

Methodology

Aims and Objectives

Aim – To compare ultrasound guided dynamic needle tip positioning and longitudinal axis in-plane technique of radial artery cannulation

Study setting and design:

After ethics committee approval and informed written consent from the participants, this randomised controlled trial will be conducted in the Department of Anaesthesiology Pain Medicine and Critical Care. The protocol will be registered in the clinical trial registry of India (www.ctri.nic.in).

Primary objective – First attempt success rate between the two techniques

Secondary objectives –

1. No of attempts and redirections

2. Time to successful cannulation

3. Posterior wall puncture

4. Hematoma formation

 

Inclusion criterion

1.     Patients undergoing general anaesthesia and requiring arterial cannulation

2.     ASA status I, II or III

3.     Age 65 years or older

Exclusion criterion

1.     Patient’s refusal to participate

2.     Hemodynamically unstable

3.     Allen’s test positive

4.     Hematoma or local site infection

5.     Known peripheral vascular disease or Raynaud’s phenomenon

Randomization

180 patients will be recruited and randomised using computer generated serial number technique into two groups

Group A – DNTP group

Group B – LAIP technique

Methods

After institutional ethics committee approval, the patients will be recruited based on inclusion and exclusion criterion. The patients will be randomly allocated to two groups. ASA standard monitors including ECG, noninvasive blood pressure and saturation probe will be attached after shifting the patients to the operation theatre (OT). The anaesthesiologist will select the right or left radial artery depending on the surgery site, location of blood pressure cuff and his/her preference. Allen’s test will be performed to confirm the patency of superficial and deep palmar arches. The wrist will be placed on a soft roll to achieve a mild dorsiflexion. The diameter of radial artery will be measured at the level of radial styloid process. The depth of radial artery will also be measured. We will be using a vascular transducer with small footprint (8–13 MHz) and a two‑dimensional SonoSite Edge2 ultrasound machine (SonoSite Inc. Bothell, WA). Depending on the randomisation group, further procedure will be carried out.

Intervention in group A – After identifying the artery in a SAX view a 20 G arterial cannula will be inserted in an out-of-plane (OOP) approach keeping the artery in the centre of the screen. The needle will be advanced in the midline till a hyperechoic dot will be visible in the centre of the screen. Then only the probe will be moved proximally without moving the needle till the hyperechoic dot just disappears. Next, keeping the probe fixed at that place, needle will then be advanced towards the radial artery till hyperechoic dot reappears. Once the needle punctures the radial artery, the probe will be moved further proximally leaving the needle tip in the centre of the radial artery. After confirmation that sufficient length of the needle tip remains in the radial artery, the outer catheter will be pushed to the end, and the stylet will be removed.

Intervention in group B – After identifying the artery in the LAX a 20G arterial cannula will be inserted keeping the longitudinal section of artery in view. The needle will be advanced in an in-plane (IP) approach visualising the whole path of the needle including the needle tip till the radial artery will be punctured. Once the radial artery is punctured the outer catheter will be pushed to the end and the stylet will be removed.

An attempt will be defined as the needle penetration from the skin. The time to cannulation will be taken from needle puncturing the skin to appearance of an arterial waveform on the monitor. This will be counted as the successful attempt. The procedure will be declared failed if the anaesthesiologist fails to cannulate the artery even after 5 attempts. The cannulation time of the successful attempt will be recorded. Hematoma will be defined by localised swelling on the puncture site.

The successful cannulation in both the groups will be recorded once the arterial waveform is obtained on the monitor. All the cannulations will be performed by consultant anaesthesiologists who performed at least more than 50 US guided radial artery cannulations by each of the techniques (5).

 
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