| CTRI Number |
CTRI/2021/05/033757 [Registered on: 24/05/2021] Trial Registered Prospectively |
| Last Modified On: |
17/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the efficacy of ultrasound guided radial arterial cannulation using two different approach. |
|
Scientific Title of Study
|
Radial arterial cannulation by Ultrasound-guided Dynamic needle tip positioning using short axis out of plane approach vs Ultrasound guided Long axis in-plane approach: A Prospective Randomized 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 Bharath Kumar Mesa |
| Designation |
MD Student |
| Affiliation |
All India Institute Of Medical Science, Raipurs |
| Address |
Department of Anesthesiology
AIIMS RAIPUR,
Chhattisgarh.
Raipur
CHHATTISGARH
492099
India |
| Phone |
8801234992 |
| Fax |
|
| Email |
bharathkumarmesa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Sinha |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences, Raipur. |
| Address |
Department of Anesthesiology,
AIIMS RAIPUR,
Chhattisgarh.
Raipur
CHHATTISGARH
492099
India |
| Phone |
9818113061 |
| Fax |
|
| Email |
drmamta12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Sinha |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences, Raipur. |
| Address |
Department of Anesthesiology,
AIIMS RAIPUR,
Chhattisgarh.
Raipur
CHHATTISGARH
492099
India |
| Phone |
9818113061 |
| Fax |
|
| Email |
drmamta12@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, Raipur, Chhattisgarh, 492099 |
|
|
Primary Sponsor
|
| Name |
AIIMS RAIPUR |
| Address |
G.E. Road, Raipur
Chattisgarh. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Bharath Kumar Mesa |
AIIMS Raipur |
B Block, OT Complex, Department of Anesthesiology,
Chattisgarh.
Raipur
CHHATTISGARH |
8801234992
bharathkumarmesa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, Raipur 492099(C.G.) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 2||Placement, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound Guided Radial Arterial Cannulation. |
Ultrasound Guided Radial Arterial Cannulation by using Dynamic needle tip positioning using short axis out of plane approach. |
| Comparator Agent |
Ultrasound guided Radial arterial cannulation. |
Ultrasound Guided Radial Arterial Cannulation by using Long axis in plane approach. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing Elective surgery requiring use of invasive arterial blood pressure monitoring |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Patients with history of forearm surgery
3. Radial artery cannulation previous 30 days
4. Abnormal Allen test.
5. Pregnant women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the first pass success rate of radial arterial cannulation by Dynamic needle tip positioning using short axis out plane approach and Long axis in plane approach . The success of first cannulation is defined as the successful insertion of the cannula with one skin puncture for the first time and the acquisition of arterial wave forms |
5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(1)Cannula insertion failure(considered to be greater than 3 cannulation attempts for a single arm or the attempted cannulation time more than 5 minutes)
(2) Number of attempts(defined as the number of skin perforations caused by the needle),
(3)Cannulation time in seconds ( defined as the interval between the first skin penetration and confirmation of the arterial waveform on the monitor)
(4)Complications (hematoma, thrombosis, vasospasm)
|
5 minutes |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/05/2021 |
| Date of Study Completion (India) |
16/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Radial artery cannulation is a common invasive procedure in perioperative period and is widely used to monitor hemodynamic status and for frequent blood sampling.It is often performed by palpation, however ultrasound guidance has shown to increase the rate of the first attempt at cannula insertion and decrease the total procedural time and incidence of cannulation related complications in adult patients. Short axis out of plane approach and long axis in plane approach are the two main approaches used in ultrasound guided vascular catheterization. Recently, a modified ultrasound technique where the needle tip is advanced in a stepwise fashion i.e. Dynamic needle tip positioning using short axis approach has been described which is shown to result in greater peripheral vascular catheterization. Very few studies have been done to compare dynamic needle tip positioning using short axis out of plane approach and long axis in plane approach . The primary aim of this study is to compare the rate of successful first attempt radial artery cannulation between Dynamic needle tip positioning using short axis out of plane approach and conventional long axis in plane approach technique. Secondary aim of this study will be to know the overall success rate within 5 minutes, median cannulation time and number of attempts. |