| CTRI Number |
CTRI/2023/05/052399 [Registered on: 09/05/2023] Trial Registered Prospectively |
| Last Modified On: |
07/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A COMPARATIVE STUDY OF RADIAL ARTERY CANNULATION USING TWO TECHNIQUES. |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF RADIAL ARTERY CANNULATION BY PALPATION TECHNIQUE VERSUS ULTRASOUND GUIDANCE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karina Viegas |
| Designation |
Junior Resident |
| Affiliation |
Goa Medical College |
| Address |
Department of Anaesthesiology, Goa Medical College, Bambolim, Goa
North Goa
GOA
403201
India |
| Phone |
9403273603 |
| Fax |
|
| Email |
karina.mviegas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chitra Juwarkar |
| Designation |
Associate Professor |
| Affiliation |
Goa Medical College |
| Address |
Department of Anaesthesiology, Goa Medical College
North Goa
GOA
403201
India |
| Phone |
9822132057 |
| Fax |
|
| Email |
juwarkarcs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Karina Viegas |
| Designation |
Junior Resident |
| Affiliation |
Goa Medical College |
| Address |
Department of Anaesthesiology, Goa Medical College, Bambolim, Goa
North Goa
GOA
403201
India |
| Phone |
9403273603 |
| Fax |
|
| Email |
karina.mviegas@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Goa Medical College |
| Address |
Goa Medical College, Bambolim, Goa |
| 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 Karina Viegas |
Goa Medical College |
Upper operation theatre, Lower operation theatre and Intensive care unit, Department of Anaesthesiology.
North Goa
GOA |
9403273603
karina.mviegas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Goa Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I779||Disorder of arteries and arterioles, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Radial artery cannulation |
Radial artery will be cannulated in patients requiring radial artery cannulation under ultrasound guidance. |
| Comparator Agent |
Radial artery cannulation |
Radial artery will be cannulated in patients requiring radial artery cannulation using palpation technique. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing elective/ emergency surgeries requiring invasive blood pressure monitoring.
2. Critically ill patients in ICU. |
|
| ExclusionCriteria |
| Details |
1. Coagulopathy
2. Infection at site
3. Raynauds phenomenon
4. Positive Allens test |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Successful cannulation at first attempt. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total number of attempts for successful cannulation. |
Baseline. |
| Time taken for successful cannulation. |
Baseline. |
| Complications of hematoma formation or vasospasm. |
Baseline. |
| Complications of infection at the site of cannulation. |
After 48 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)
|
01/06/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 line cannulations are performed in patients mainly for invasive blood pressure monitoring which is essential in major surgical and critically ill patients and for blood sampling for arterial blood gas analysis for managing sick patients. Radial artery is most commonly chosen for arterial cannulation for its ease of access, presence of collateral circulation. reliable straight course and high success rate. Aim of this study is to compare palpation technique and ultrasound guided radial artery cannulation. |