| CTRI Number |
CTRI/2023/08/056691 [Registered on: 21/08/2023] Trial Registered Prospectively |
| Last Modified On: |
19/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparing ultrasound-guided dynamic needle tip positioning technique to conventional palpation technique for Radial arterial cannulation |
|
Scientific Title of Study
|
Ultrasound-guided dynamic needle tip positioning technique versus conventional palpation technique for radial arterial cannulation-a randomized study |
| 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 Suneela Channabasappa Biradar |
| Designation |
PG Resident Anaesthesiology |
| Affiliation |
M S Ramaiah Medical College |
| Address |
Department of Anaesthesiology
M S Ramaiah Medical College Bangalore
New BEL Road
MSRIT Post Bangalore
Bangalore
KARNATAKA
560054
India
Bangalore KARNATAKA 560054 India |
| Phone |
9108185406 |
| Fax |
|
| Email |
sunilbiradar36@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Yatish B |
| Designation |
Professor |
| Affiliation |
M S Ramaiah Medical College |
| Address |
Department of Anaesthesiology
M S Ramaiah Medical College Bangalore
New BEL Road
MSRIT Post Bangalore
Bangalore
KARNATAKA
560054
India
Bangalore KARNATAKA 560054 India |
| Phone |
9886197658 |
| Fax |
|
| Email |
yatishseeni@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Yatish B |
| Designation |
Professor |
| Affiliation |
M S Ramaiah Medical College |
| Address |
Department of Anaesthesiology
M S Ramaiah Medical College Bangalore
New BEL Road
MSRIT Post Bangalore
Bangalore
KARNATAKA
560054
India
Bangalore KARNATAKA 560054 India |
| Phone |
9886197658 |
| Fax |
|
| Email |
yatishseeni@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| MS Ramaiah Medical College MSRIT Post
New BEL Road
Bangalore
560054 |
|
|
Primary Sponsor
|
| Name |
MS Ramaiah Medical College |
| Address |
New BEL Road
MSRIT Post
MSR Nagar
Bangalore
560054 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suneela Channabasappa Biradar |
MS Ramaiah Medical College Hospital |
Department Of Anaesthesiology Second Floor MS Ramaiah Medical College Hospital New BEL Road Bangalore
Bangalore
Karnataka Bangalore KARNATAKA |
9108185406
sunilbiradar36@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MS Ramaiah Medical College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Radial Arterial Cannulation |
Ultrasound Guided Radial arterial cannulation Using Dynamic Needle Tip Positioning Technique |
| Comparator Agent |
Radial Arterial Cannulation |
Radial Arterial Cannulation Using Conventional Palpatory Method |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing an elective surgical procedure that required the use of invasive arterial pressure monitoring aged between 18 to 60 years. |
|
| ExclusionCriteria |
| Details |
History of forearm surgery
Skin infection at the puncture site
Abnormal modified Allen test
Coagulation dysfunction
Pregnant female
Had radial artery cannulation in last 30 days |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the first pass success rate between Dynamic needle tip positioning technique & conventional palpation technique for radial
artery cannulation |
successfully obtaining an arterial waveform after one
pass through the skin with the needle within 5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the cannulation time & number of skin punctures between Dynamic needle tip positioning technique and conventional palpation technique for Radial arterial cannulation |
Overall success of obtaining an arterial waveform within 5 minutes & number of skin punctures |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/08/2023 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Arterial cannulation is a common invasive procedure performed in the emergency room, ICU and operating room indicated especially in major operation and critical patients to monitor beat to beat hemodynamic changes. Radial artery is most commonly used due to its superficial course, dual blood supply of the hand, and low risk of complications. Radial artery cannulation was traditionally performed by palpation of radial artery pulsation. USG guided techniques have been widely used in various vascular cannulations because of its visual characteristics and higher success rate of cannulation compared with traditional palpation. Dynamic needle tip positioning is a new modified ultrasound technique that is shown to result in greater peripheral venous catheterization success rate when compared to long-axis in-plane view in a phantom model.Use of this method for radial arterial cannulation was described in a case report by Goh et al. The dynamic needle tip positioning method combines the advantages of short-axis out of plane and long-axis in-plane ultrasound techniques. Very few studies have been done comparing this new modification of ultrasound technique with traditional palpation technique. Therefore, we propose to conduct this study and hypothesize that this new technique would result in significant increase in first pass success rate of radial artery cannulation. |