| CTRI Number |
CTRI/2021/04/033245 [Registered on: 29/04/2021] Trial Registered Prospectively |
| Last Modified On: |
29/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Cannulation of Distal Radial Artery by palpation and ultrasound guidance and comparing which is a better method. |
|
Scientific Title of Study
|
Comparison of perioperative ultrasound guided versus palpatory method of cannulation of distal radial artery: A Randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pratik Tuppad |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences, Rishikesh |
| Address |
Department of Anaesthesiology
AIIMS Rishikesh
Virbhadra Road
Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7259263865 |
| Fax |
|
| Email |
pratiktuppad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences , Rishikesh |
| Address |
Department of Anaesthesiology
AIIMS Rishikesh
Virbhadra Road
Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9340482058 |
| Fax |
|
| Email |
ajaymishra0701@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences , Rishikesh |
| Address |
Department of Anaesthesiology
AIIMS Rishikesh
Virbhadra Road
Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9340482058 |
| Fax |
|
| Email |
ajaymishra0701@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
AIIMS, Rishikesh |
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
Virbhadra Road,Shivaji Nagar, near Barrage, Sturida Colony, Rishikesh, Uttarakhand 249203 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pratik Tuppad |
AIIMS Rishikesh |
Department of Anaesthesia, Level 6, IPD building.
Dehradun
UTTARANCHAL |
7259263865
pratiktuppad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I083||Combined rheumatic disorders of mitral, aortic and tricuspid valves, (2) ICD-10 Condition: I257||Atherosclerosis of coronary arterybypass graft(s) and coronary artery of transplanted heart with angina pectoris, (3) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere, (4) ICD-10 Condition: I279||Pulmonary heart disease, unspecified, (5) ICD-10 Condition: Q210||Ventricular septal defect, (6) ICD-10 Condition: Q211||Atrial septal defect, (7) ICD-10 Condition: C383||Malignant neoplasm of mediastinum,part unspecified, (8) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (9) ICD-10 Condition: I362||Nonrheumatic tricuspid (valve) stenosis with insufficiency, (10) ICD-10 Condition: Q225||Ebsteins anomaly, (11) ICD-10 Condition: Q232||Congenital mitral stenosis, (12) ICD-10 Condition: I089||Rheumatic multiple valve disease,unspecified, (13) ICD-10 Condition: I342||Nonrheumatic mitral (valve) stenosis, (14) ICD-10 Condition: I358||Other nonrheumatic aortic valve disorders, (15) ICD-10 Condition: I340||Nonrheumatic mitral (valve) insufficiency, (16) ICD-10 Condition: I371||Nonrheumatic pulmonary valve insufficiency, (17) ICD-10 Condition: 4||Measurement and Monitoring, (18) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Distal radial artery cannulation by palpatory method |
The operator will palpate the distal radial arterial pulse with their nondominant hand at the point where the axis passing through the index finger and the thumb meet. The needle will be advanced toward the distal radial artery at a 15° to 30° angle until a flash back of blood is observed in the needle hub. The artery is said to be successfully cannulated once there is appearance of the waveform on the monitor. |
| Comparator Agent |
Distal radial artery cannulation by ultrasound guided method |
The research team will use ultrasound machine (vivid iq: GE medical system (China) co. ltd., Jiangsu, P.R. China) and probe (12L-RS; GE Health Care co, Tokyo, Japan) to obtain an image of the distal radial artery at the estimated point of needle puncture. Under strict asepsis, an anesthesiologist
will image radial artery using linear probe by out of plane view technique. The needle will be advanced through the skin at a 30 to 40 degree angle until the hyperechoic needle tip is seen on the ultrasound image. The ultrasound probe will then be moved proximally along the arm and away from the needle insertion point until the needle tip disappears from the ultrasound image The needle will then be advanced a few millimeters until the needle tip is seen again on the ultrasound image and blood starts flowing out of the needle hub (dynamic needle tip positioning). A guidewire will be threaded through the needle hub. After confirmation of guidewire in the radial artery, the catheter will be rail -roaded over it. Guide wire will be removed and high-pressure line
will be attached at the catheter hub and pressure waves will be confirmed on the monitor. Pressure waves on the monitor will be the culmination of the procedure. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18 – 65 years
2. American Society of Anesthesiology physical Status (ASA PS) I-III
3. Patients undergoing elective major surgeries requiring arterial
cannulation. |
|
| ExclusionCriteria |
| Details |
1. Absent or feeble arterial pulsation.
2. Refusal to participate.
3. Severe hypotension requiring inotropes.
4. Hemorrhagic shock
5. Skin erosions near the insertion site.(infection)
6. morbid obesity
7. History of peripheral vascular disease
8. Patients with negative Modified Allen’s test
9. Emergency surgeries
10. American society of Anaesthesiology physical status (ASA-PS)
IV
11. Age below 18 years and above 65 years |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of first attempt success rate |
5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare degree of bias in MAP measurement obtained from distal
radial artery and femoral artery.
2. To compare the total number of attempts for successful cannulation.
3. To compare the cannulation time.
4. To compare the complication with multiple attempts
5. To compare the ease of cannulation and ergonomics for the
anaesthesiologist using the VAS (visual analog scale).
|
24 hours |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
03/05/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Radial artery has been used for invasive arterial BP monitoring and serial ABG sampling. Distal radial artery (DRA) has been used for coronary angiography and intervention . We have proposed that DRA can be used for Invasive BP monitoring and serial ABG sampling as well. The advantage over the conventional site being, possible less incidence of complications as the DRA has given off enough collateral arteries to the digits. We want to compare the first pass success rate between ultrasound guided cannulation of DRA and palpatory method of cannulation . |