| CTRI Number |
CTRI/2021/02/031051 [Registered on: 05/02/2021] Trial Registered Prospectively |
| Last Modified On: |
26/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of USG-guided and blind techniques for radial artery cannulation by residents in a teaching institute. |
|
Scientific Title of Study
|
A Randomised comparison of ultrasound- guided versus palpation techniques for Radial artery cannulation by residents in a teaching institution. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Afroz Khan |
| Designation |
Assistant Professor |
| Affiliation |
Grant government medical college |
| Address |
6th floor Department of Anaesthesia & Critical Care,Main building, Grant Government Medical College & Hospital, Byculla, Mumbai-08
Quaretr no 11, Panchasheel building, JJ Hospital, Byculla, Mumbai-08
Mumbai
MAHARASHTRA
400008
India |
| Phone |
09167296754 |
| Fax |
|
| Email |
drafrozkhan2003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Afroz Khan |
| Designation |
Assistant Professor |
| Affiliation |
Grant government medical college |
| Address |
6th floor Department of Anaesthesia & Critical Care,Main building, Grant Government Medical College & Hospital, Byculla, Mumbai-08
Quarter no 11, Panchasheel building, JJ Hospital, Byculla, Mumbai-08
Mumbai
MAHARASHTRA
400008
India |
| Phone |
09167296754 |
| Fax |
|
| Email |
drafrozkhan2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Afroz Khan |
| Designation |
Assistant Professor |
| Affiliation |
Grant government medical college |
| Address |
6th floor Department of Anaesthesia & Critical Care,Main building, Grant Government Medical College & Hospital, Byculla, Mumbai-08
Quarter no 11, Panchasheel building, JJ Hospital, Byculla, Mumbai-08
Mumbai
MAHARASHTRA
400008
India |
| Phone |
09167296754 |
| Fax |
|
| Email |
drafrozkhan2003@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Afroz Shahana M Khan |
| Address |
6th floor, Department of Anaesthesia & Critical Care, Main building, JJ Hospital, Byculla, Mumbai. |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Afroz Shahana M Khan |
Grant Government Medical College and Sir J.J. Group Of Hospitals, Mumbai |
Department of Anaesthesia & CRitical care, 6th Floor, Main building, JJ Hospital, Byculla, Mumbai 08.
Mumbai
MAHARASHTRA |
09167296754
drafrozkhan2003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Department Of Pharmacology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C716||Malignant neoplasm of cerebellum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Palpation technique for radial artery cannulation. |
For securing radial artery cannulation, radial artery would be palpated with three fingers in wrist extention position and cannulation will be secured by blind technique. |
| Intervention |
Ultrasound-guided radial artery cannulation. |
a portable ultrasound device (Venue, GE Healthcare, Chicago, IL) was applied to the skin to localize the radial artery and a 20-gauge catheter was inserted distal to the transducer and directed according to the ultrasound image. Start time was defined when the ultrasound machine was placed on the wrist. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
a. Adult patients undergoing high risk surgeries where invasive BP monitoring is needed.
b. Patients willing to give consent
c. Trained postgraduate 3rd year (PGY-3) anesthesiology residents (at least 5 TBP and 5 USG radial arterial catheterizations prior to the study).
|
|
| ExclusionCriteria |
| Details |
a. American Society of Anaesthesiologist class V.
b. Patients not willing to give consent.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the number of patients whose arterial catheter successfully inserted at the first attempt |
At the end of the study i.e 2 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. The study the number of attempts needed for successful arterial catheter placement in both the methods.
2. To assess the time required for successful cannulation.
3. To evaluate number of sites used for successful cannulation.
4. To figure out total catheters being used for cannulation.
5. To determine rate of complications and total number of operators required in both the methods.
|
At the end of the study i.e 2 months. |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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)
|
15/02/2021 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized, parallel-group, single-center study
comparing the palpatory method and ultrasound-guided radial artery cannulation. The primary outcome will measure the number of patients whose arterial catheter
successfully inserted at the first attempt. The secondary outcomes will measure
number of attempts needed for successful arterial catheter placement in both
the methods, the time required for successful cannulation, the number of sites used
for successful cannulation, total catheters being used for cannulation, rate of
complications and a total number of operators required in both the methods.
|