CTRI Number |
CTRI/2021/07/034730 [Registered on: 09/07/2021] Trial Registered Prospectively |
Last Modified On: |
07/12/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Study comparing two ultrasound techniques for Radial artery cannulation in adult patients undergoing Cardiac Surgery. |
Scientific Title of Study
|
Prospective randomized Study of Ultrasound- Guided Out-of-Plane vs In-Plane Radial Artery Cannulation in Adult Cardiac Surgical Patients |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Achinthya Roopa Arul |
Designation |
Junior Resident |
Affiliation |
Kasturba Medical College |
Address |
Department of Anaesthesiology
Kasturba Medical College
Tiger Circle Road
Manipal Tiger Circle Road
Madhav Nagar
Manipal
Udupi- 576104 Udupi KARNATAKA 576104 India |
Phone |
9047133111 |
Fax |
|
Email |
achinthyaarul@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Vijayakumara |
Designation |
Associate Professor |
Affiliation |
Kasturba Medical College |
Address |
Department of Anaesthesiology
Kasturba Medical College
Tiger Circle Road
Manipal Tiger Circle Road
Madhav Nagar
Manipal
Udupi- 576104 Udupi KARNATAKA 576104 India |
Phone |
8970213332 |
Fax |
|
Email |
vijaysd84@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Vijayakumara |
Designation |
Associate Professor |
Affiliation |
Kasturba Medical College |
Address |
Department of Anaesthesiology
Kasturba Medical College
Tiger Circle Road
Manipal Tiger Circle Road
Madhav Nagar
Manipal
Udupi- 576104 Udupi KARNATAKA 576104 India |
Phone |
8970213332 |
Fax |
|
Email |
vijaysd84@gmail.com |
|
Source of Monetary or Material Support
|
Kasturba Medical College, Manipal |
|
Primary Sponsor
|
Name |
Kasturba Medical College Manipal |
Address |
KH , manipal |
Type of Sponsor |
Research institution and hospital |
|
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 |
Achinthya Roopa Arul |
Kasturba Medical College |
Department of Anaesthesiology
Tiger Circle Road
Madhav Nagar
Manipal
Udupi- 576104 Udupi KARNATAKA |
9047133111
achinthyaarul@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Kasturba Medical college and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
In plane ultrasound guided radial artery cannulation. |
Group A-The patients posted for elective cardiac surgery requiring radial artery cannulation for monitoring will be included in this study.• In the operating room after attaching monitors and noting the base line vitals, the patient’s hand (preferably left hand) will be positioned in dorsiflexion at approximately 45 degrees and fixed over a roll in order to ensure maximum radial artery diameter. The radial artery will then be approached under strict aseptic precautions using a 20 G catheter under local anesthesia (one to two ml of plane lignocaine hydrochloride). J tip ultrasound probe will be used. The procedure will be performed in all patients by the same Anesthesiologist taking part in the study. The J probe will be placed parallel to the radial artery and cannulation will be done in the in plane view. Data such as Successful first pass radial artery cannulation, Number of redirections, Cannulation completion time, Number of attempts to cannulate the artery, Number of failed attempts and incidence of vascular complications such as hematoma, thrombosis, posterior arterial wall puncture will be recorded |
Comparator Agent |
Out of plane ultrasound guided radial artery cannulation. |
Group B-The patients posted for elective cardiac surgery requiring radial artery cannulation for monitoring will be included in this study.• In the operating room after attaching monitors and noting the base line vitals, the patient’s hand (preferably left hand) will be positioned in dorsiflexion at approximately 45 degrees and fixed over a roll in order to ensure maximum radial artery diameter. The radial artery will then be approached under strict aseptic precautions using a 20 G catheter under local anesthesia (one to two ml of plane lignocaine hydrochloride). J tip ultrasound probe will be used. The procedure will be performed in all patients by the same Anesthesiologist taking part in the study. The J probe will be placed perpendicular to the radial artery and cannulation will be done in the out of plane view. Data such as Successful first pass radial artery cannulation, Number of redirections, Cannulation completion time, Number of attempts to cannulate the artery, Number of failed attempts and incidence of vascular complications such as hematoma, thrombosis, posterior arterial wall puncture will be recorded |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Adult elective cardiac surgical patients
Age group of 18-70 years
All cardiac surgeries requiring radial artery cannulation
|
|
ExclusionCriteria |
Details |
Patients with
Negative Allen’s test
Patients with EF less than 40%
Ulnar artery occlusion
Atherosclerotic vascular disease
Cardiogenic Shock
Morbid obesity
Raynaud’s disease
Peripheral vascular disease
Coagulation disorders
Skin infection over insertion site
Emergency cardiac surgeries
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Time taken for successful first pass radial artery cannulation
|
Time will be measured from first skin prick to successful placement of cannula into the artery indicated by typical pulsatile back flow of blood
|
|
Secondary Outcome
|
Outcome |
TimePoints |
Number of redirections
|
will be assessed during cannulation |
Cannulation completion time |
Time will be measured from first skin prick to successful placement of cannula into the artery indicated by typical pulsatile back flow of blood
|
Number of attempts to cannulate the artery |
Will be assessed during cannulation |
Number of failed attempts |
Will be assessed during cannulation |
Incidence of vascular complications |
will be assessed during cannulation and 15 min after and post op. |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "128"
Final Enrollment numbers achieved (India)="128" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/08/2023 |
Date of Study Completion (India) |
02/11/2022 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
02/11/2022 |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Arterial cannulation is a frequently used procedure to monitor the beat to beat arterial pressure, assessment of fluid responsiveness and can be used for frequent arterial blood sampling in the interoperative period. The radial artery is frequently chosen for its superficial location and availability of dual blood supply to the hand via the ulnar artery in the occasion of a complication. Traditionally used land mark technique has shown to require multiple attempts and frequent occurrence of bleeding and arterial spasm thereby leading to patient discomfort. With the introduction of ultrasound into medical practice and the emergence of Point of Care ultrasound, these concerns can be solved. Successful arterial cannulation can be a challenge in patients who are obese and in patients with edema, hypotension or vascular anomalies. Ultrasound guidance can be more effective than palpation for insertion of a radial artery cannula in such patients. Point of care ultrasound is defined as ultra-sonography brought to the patient and performed by the provider in real time. It can be used to enhance diagnostic and procedural accuracy. High frequency probes (7MHz) are preferred over lower frequency probes (<5MHz) because they provide better resolution of superficial structures in close proximity to the skin surface. The poorer penetration of high frequency probes id typically not a hinderance, because most target vascular structures intended for cannulation are <8 to 10 cm from the skin surface. In this study we aim to compare the rate of successful first pass radial artery cannulation in the In-Plane vs Out-of-Plane ultrasound guided techniques. Arora et al in 2020 compared the rate of first pass radial artery cannulation using out- of plane vs in-plane imaging. It was a prospective, randomised, observational study carried out in a tertiary care centre. They compared 84 adult patients undergoing cardiac surgery after dividing them into out-of-plane USG group (n=42) and in-plane USG group (n=42). In each approach, the number of times first pass success was achieved, number times the cannula was redirected, number of skin punctures, incidence of hematomas, and number of failed attempts were noted. The first-pass success rate was statistically significant (p=0.007) in the In-Plane USG group. A larger number of patients in the Out-of-Plane group required redirection of cannula (p= 0.002). The number of times skin needed to be punctured was also greater in the Out-of-plane group as compared to the In-Plane group (p= 0.002). The time taken for completion of cannulation and the incidence of hematomas were similar in both the groups. They concluded that the In-plane Ultrasound technique was superior in achieving a higher first pass success rate and also ensuring minimal redirections and reduced number of skin punctures. Sethi et all in 2016 also did a comparison of the Short- axis out-of-plane (SA-OOP) and the long-axis in-plane (LA-IP) USG guided radial artery cannulation in adult patients. It was a prospective, randomized controlled trial. 150 patients of ASA class 1- 3 and between the age group of 18-70 were included. They were randomized into two groups of 75 each. The primary out come was successful cannulation in the first attempt. First attempt arterial cannulation was successful in 80% of patients in the SA-OOP group when compared to 82.6% in the LA-IP group. Time to successful cannulation of the artery was similar in the two groups. But time to localize the artery was higher in the LA-OOP technique (p>0.001). Hence they concluded that the rate of first pass success and the time taken for completion of arterial cannulation was similar in both the techniques. Zeng et all in 2020 did a study comparing Oblique axis/In-plane (OA-IP) versus longitudinal axis/in-plane (LA-IP) approach for ultrasound guided radial artery cannulation. 60 surgical patients in the age group of 18-70 years, and falling in ASA class 1-3 were selected. They required invasive arterial line for monitoring. The primary objective was to compare the first attempt success rate in OA-IP as compared to LA-IP. They inferred thar the first attempt success rate was higher (93.3% vs 60%, p= 0.005) in the OA-IP technique when compared to the LA-IP technique. The OA-IP technique was also associated with shorter cannulation time and fewer injuries. Wilson Et all in 2019 did a comparison between ultrasound guided vs traditional palpation technique which was carried out by residents. 60 patients above the age of 18 requiring arterial cannulation for invasive monitoring or frequent blood sampling were recruited. The were randomized in to either groups. Their results showed that the ultrasound guided arterial cannulation group required fewer attempts as compared to the palpation technique group (96% vs 47%). They concluded that the residents were more successful and had fewer cannulation attempts with the ultrasound guided technique when compared to traditional arterial cannulation after standard intern-level ultrasound training. Hansen Et all in 2014 compared Ultrasound guided dynamic needle tip positioning radial artery cannulation to traditional landmark technique. It was a randomized, patient blinded, crossover study. The patients underwent bilateral radial artery cannulation using both techniques. The primary objective was to determine the difference in needle manipulation time. Forty patients were analyzed. There was no significant difference in the needle manipulation time. In the traditional palpation technique there was use of a higher number of skin perforations, catheters and attempts at targeting the vessel. First attempt success was significantly higher in the ultrasound dynamic needle tip positioning group. They concluded that the ultrasound dynamic needle tip positioning technique significantly improves the clinically relevant parts of the procedure.
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