| CTRI Number |
CTRI/2022/11/047785 [Registered on: 30/11/2022] Trial Registered Prospectively |
| Last Modified On: |
29/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Blind versus Ultrasound Guided Methods to attain Radial Artery Cannula Access |
|
Scientific Title of Study
|
Comparative Study of Radial Artery Cannulation by Conventional Palpatory Method versus USG Guided Technique in Adult Patients Undergoing Elective Surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aman Shukla |
| Designation |
PG Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
C-9/9491, Vasant Kunj, New Delhi
South West DELHI 110070 India |
| Phone |
9717483727 |
| Fax |
|
| Email |
amanxshukla@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr G Usha |
| Designation |
Professor and Consultant |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology, VMMC and Safdarjung Hospital, Ansari Nagar East, New Delhi
South DELHI 110029 India |
| Phone |
8447795934 |
| Fax |
|
| Email |
doctorgusha@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr G Usha |
| Designation |
Professor and Consultant |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology, VMMC and Safdarjung Hospital, Ansari Nagar East, New Delhi
DELHI 110029 India |
| Phone |
8447795934 |
| Fax |
|
| Email |
doctorgusha@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College, New Delhi |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi, Delhi 110029 |
| 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 |
| Aman Shukla |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anaesthesiology, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi, Delhi 110029 South DELHI |
9717483727
amanxshukla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjung Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Radial Artery Cannulation |
The trial will be done to compare the two methods of achieving radial artery cannulation- palpatory vs the USG guided technique.
The cannulation procedure will be done only after the patient posted for major elective surgery is induced under anaesthesia. Non-dominant hand will be chosen, local anaesthesia will be applied at the site of radial artery access. The equipment will be setup and all the cannulations will be done with a 20G catheter of the same make under strict aseptic precautions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade I and II patients.
2. Age group of 18 to 65 years of either gender.
3. Patients posted for elective major surgery. |
|
| ExclusionCriteria |
| Details |
1. Coagulation defects/anticoagulant therapy
2. Obesity defined by body mass index > 30kg/m2
3. Patients in shock
4. Patients who have received radial artery cannulation within previous 30 days
5. Local lesions/ burns/ orthopaedic defects/ grafts
6. Negative Modified Allen’s test
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare first attempt success rates of conventional palpatory method and ultrasound guided technique for radial artery cannulation in adult patients undergoing elective major surgery. |
Just after anaesthetic induction of patient and before the beginning of surgical procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare overall success rates of conventional palpatory method and USG guided technique for radial artery cannulation in adult patients undergoing elective major surgery. |
Just after anaesthetic induction of patient and before the beginning of surgical procedure. |
| To compare time taken for successful cannulation by conventional palpatory method and ultrasound guided technique for radial artery cannulation in adult patients undergoing elective major surgery. |
Just after anaesthetic induction of patient and before the beginning of surgical procedure. |
|
|
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)
|
01/12/2022 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
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 procedure which is very often put into use in acute and critical care settings. It is an invasive means to measure the blood pressure and mean arterial pressure more accurately as well as to provide beat to beat assessment of hemodynamic status in critical situations compared to the non-invasive means. In addition, it is very useful for repeated sampling of ABG in critical care settings. Continuous invasive blood pressure monitoring is of extreme importance for monitoring patients who are in a critical condition or those who are undergoing a major surgery. Although non-invasive blood pressure measurement is generally safe, it can lead to rare but severe complications. One possibility is that of compartment syndrome, which can develop after prolonged periods of frequent cycling and mostly observed in situations such as trauma to the limb, hypovolemic shock or impaired distal limb perfusion. Arterial cannulation needs technical expertise for placement and management. Despite drawbacks such as high risk, invasive procedure, associated complications, and high cost involved, it is still the accepted reference standard for blood pressure monitoring. Arterial cannulation is indicated if there is need for continuous, real-time blood pressure monitoring, anticipated pharmacological or mechanical cardiovascular manipulation, need for repeated blood sampling, failure of indirect arterial blood pressure management or requirement of supplementary diagnostic information from arterial waveform. For invasive blood pressure monitoring, various arteries can be used including the radial, brachial, axillary, femoral and dorsalis pedis arteries. The most common access for real time blood pressure monitoring is gained via radial artery cannulation. This is so because the radial artery runs a superficial course, has fewer complications, and the hand has a dual blood supply. Before cannulating the radial artery, assessment of collateral blood flow by the modified Allen’s test is mandatory. Though Allen’s test is the only tool available for assessment of efficiency of collateral circulation in hand, unfortunately, predictive value of this test has been found to be poor and prognostic value of this test in detecting adequate collateral circulation is unconfirmed. Radial artery cannulation by palpatory (conventional) method is achieved mainly by three techniques: direct arterial puncture, guidewire assisted cannulation (Seldinger technique), and the transfixion withdrawal method. In recent years, ultrasonography-guided radial artery cannulation has become a common method to access the radial artery. Ultrasound guided technique offers a direct view of the vessel lumen followed by guiding the cannula directly inside the lumen avoiding damage either to the vessel or adjacent structures. There are studies that have also shown that ultrasonography-guided radial artery cannulation improves the first attempt success rate for cannula insertion and also consumes less time as compared to the conventional palpatory method. However, there is a learning curve for achieving expertise in the ultrasound guided technique. On review of literature for studies, we found that there is a paucity of research materials with respect to comparing the conventional and ultrasound guided techniques of arterial cannulation particularly in Indian population. We are undertaking a study comparing conventional palpatory method of radial artery cannulation with that of ultrasound technique for radial arterial cannulation in Indian adults posted for elective major surgical procedures. |