| CTRI Number |
CTRI/2024/09/073255 [Registered on: 03/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Prospective Randomized Comparative Study] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To Compare The Time Taken For Radial Artery Cannulation In Three Different Techniques in Cardiac Surgery Patients |
|
Scientific Title of Study
|
A Randomized, Comparative Study For The Efficacy Of Three Techniques For Radial Artery Cannulation In Cardiac Surgery Patients At SMS Hospital, Jaipur |
| 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 Reema Meena |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical college and Hospital |
| Address |
Department of anaesthesiology, second floor, Dhanvantri building, JLN marg, Jaipur, Rajasthan.
Jaipur
RAJASTHAN
302001
India |
| Phone |
9413237117 |
| Fax |
|
| Email |
reemadr.rn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reema Meena |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical college and Hospital |
| Address |
Department of anaesthesiology, second floor, Dhanvantri building, JLN marg, Jaipur, Rajasthan.
RAJASTHAN
302001
India |
| Phone |
9413237117 |
| Fax |
|
| Email |
reemadr.rn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kashan Faris I |
| Designation |
Junior Resident |
| Affiliation |
sawai man singh medical college and hospital |
| Address |
Department of anaesthesiology, second floor, Dhanvantri building, JLN marg, Jaipur, Rajasthan.
Jaipur
RAJASTHAN
302001
India |
| Phone |
8760363309 |
| Fax |
|
| Email |
kashanfaris65@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology, sawai man singh medical college and hospital, Jaipur, Rajastan, India - 302004 |
|
|
Primary Sponsor
|
| Name |
Sawai Man Singh Medical College and Hospital |
| Address |
Department of Anaesthesiology, second floor, Dhanvantri building, JLN marg , Jaipur, India - 302004 |
| Type of Sponsor |
Government 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 Reema Meena |
SMS Medical College and Hospital,Jaipur |
Dept. of anaesthesia, cardiac surgery ot, second floor, bangad building, JLN marg, Jaipur - 302004
Jaipur
RAJASTHAN |
9413237117
reemadr.rn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the Ethics Committee,,SMS Medical College and Attached Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I089||Rheumatic multiple valve disease,unspecified, (2) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, (3) ICD-10 Condition: I269||Pulmonary embolism without acute cor pulmonale, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparison of the Efficacy Of Three Techniques For Radial Artery Cannulation In Cardiac Surgery Patients |
comparison of Number of attempts,Time variables {ultrasound scanning time, skin puncture to blood flashback, blood flashback to catheter insertion), Total procedure time,Complications between three techniques of radial artery cannulation.
|
| Intervention |
Group A : Ultrasound-guided Dynamic Needle Tip Positioning(DNTP) technique will be used for radial artery cannulation. |
In the DNTP group, short-axis out-of-plane view of the ra¬dial artery will be obtained and the ultrasound probe will be moved three cm proximally along the course of the radial artery to examine the patency of the artery.For the DNTP technique the needle will be introduced at a 30° to 45° angle until the needle tip will be visualised as a hyperechoic dot. With the needle kept in place, the ultra¬sound probe will be moved a few millimeters prox¬imally until the needle tip disappeared. The needle will then be advanced until the hyperechoic dot (the needle tip) reappeared on the display. After puncture of ante¬rior wall of the radial artery, the needle tip will be located in the lumen of the vessel. After checking for blood flashback, the angle of the needle will be lowered and the needle will be advanced further keeping the hyperechoic dot in the middle of the vessel lumen. The process will be repeated until there was greater than 1 cm of needle insertion into the lumen. The catheter will then be introduced into the artery. |
| Intervention |
Group B : Ultrasiund guided Longaxis-In-Plane technique will be used for radial artery cannulation |
In the Longaxis-In-Plane(LAX-IP) group, the radial ar¬tery will be identified after obtaining the short-axis out-of-plane view, the probe will be rotated 90° to visualize the radial artery in the long-axis in-plane view. The cross-sectional area along with the depth of the artery, will be measured post hoc by a blinded researcher.For the LAX-IP group, the needle will be intro¬duced and finely adjusted during insertion such that the whole length of the needle visual¬ized in the long-axis display. After confirmation of flashback, the needle angle will be decreased and the needle will be inserted 1-2 mm further while keeping the needle tip visualized within the arte¬rial lumen. The catheter sheath will be com¬pletely introduced into the radial artery, and then pressure transducer tube will be connected to the catheter. Successful arterial cannulation will be confirmed by arterial pressure waveform displayed on the patient monitor. |
| Intervention |
Group C : Conventional Palpation technique will be used for radial artery cannulation. |
In conventional palpation technique, the non-dominant hand is used to palpate the radial artery 1 to 2cm proximal to the wrist. The needle is then inserted in a proximal direction, at a 30 to 45-degree angle while watching for a blood flash. There should be bright red pulsatile blood returned with the correct vessel |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Informed written consent
|
|
| ExclusionCriteria |
| Details |
1.Skin infection at the puncture
2.ASA classification more than or equal to 4.
3.Patient who had received radial artery cannulation within the previous 30 days
4.History of Raynaud syndrome.
5.Peripheral vascular disease.
6.Coagulopathy with significant bleeding tendency before surgery.
7.Morbid obesity Body Mass Index more than 40
8.Negative modified Allen’s test.
9.Patient who doesn’t give consent.
10.Patients who is included in any other study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the difference in first attempt success rate of radial artery cannulation among the three groups.
2.To assess the overall success rate.
3.To assess the overall procedure time.
4.To assess the number of attempts.
|
1.Number of attempts at baseline
2.First attempt success rate at baseline
3.Ultrasound scanning time at baseline
4.Skin puncture to blood flashback time at baseline
5.Blood flashback to catheter insertion time at baseline
6.Total procedure time at baseline
7.Complications if any.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the procedure related complications. |
At baseline time, Complications if any such as Vasospasm, Posterior wall puncture, Thrombosis, Hematoma will be noted. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
28/09/2024 |
| 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="0"
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
|
Patient
taken in OT
NBM
status, PAC consent will be checked.
Patient
demographic data are taken (Age, Sex, BMI, NIBP)
Routine
vital monitors attached for ECG, SpO2, EtCO2, Entropy Peripheral IV line, IJV
central line
After
randomisation, Patients (n=150) will be allocated into specific group by sealed
envelope method
DNTP LAX-IP Conventional Palpation Method
Radial
artery profiles are taken such as Left/Right cross-
sectional area & depth
Radial artery cannulation procedure is done
Time
variables are noted such as Ultrasound scanning time, Skin puncture to blood
flashback, Blood flashback to catheter insertion, Total procedure time
Procedural
data are recorded such as First attempt success rate, Number of attempts- 1/2/3
Baseline
characteristics are noted such as HR, SBP, DBP, MBP (Invasive)
Complications if any such as Vasospasm, Posterior wall puncture,
Thrombosis, Hematoma will be noted |