| CTRI Number |
CTRI/2021/12/038611 [Registered on: 14/12/2021] Trial Registered Prospectively |
| Last Modified On: |
15/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ultrasound guided radial artery cannulation with using acoustic shadow |
|
Scientific Title of Study
|
Effect of acoustic shadowing on ease of ultrasound guided radial artery cannulation in adults. 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 |
Rajnish Kumar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Patna |
| Address |
Department of Anesthesiology
IPD Building, B5A, Room No 503
Phulwarisharif
AlIMS Patna
Patna
BIHAR
801507
India |
| Phone |
|
| Fax |
|
| Email |
drraj76pmch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajnish Kumar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Patna |
| Address |
Department of Anesthesiology
IPD Building, B5A, Room No 503
Phulwarisharif
AlIMS Patna
Patna
BIHAR
801507
India |
| Phone |
|
| Fax |
|
| Email |
drraj76pmch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajnish Kumar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Patna |
| Address |
Department of Anesthesiology
IPD Building, B5A, Room No 503
Phulwarisharif
AlIMS Patna
Patna
BIHAR
801507
India |
| Phone |
|
| Fax |
|
| Email |
drraj76pmch@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
AIIMS Patna |
|
|
Primary Sponsor
|
| Name |
AIIMS Patna |
| Address |
Department of Anesthesiology
IPD Building, B5A, Room No 503
Phuwarisharif
Patna 801507
|
| 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 |
| Rajnish Kumar |
AIIMS Patna |
Fifth Floor operation room complex
IPD Building Room No 503
Phulwarsharif
AIIMS Patna 801507
Patna
BIHAR |
7783865337
drraj76pmch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee AIIMS Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 2||Placement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasound guided radial artery cannulation |
Using USG high frequency 13MHz linear probe for radial artery cannulation |
| Intervention |
Using acoustic shadow during USG guided radial artery cannulation |
Acoustic shadowing shall be utilised during conventional usage of USG to guide arterial cannulation. High frequency linear probe 13MHz will be used for radial artery cannulation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between the ages of 18-70 years
2. American society of Anaesthesiology physical status class I, II and III
|
|
| ExclusionCriteria |
| Details |
1. Coagulation Disorder
2. Failed Allen’s Test
3. Abnormal Ulnar Arter.
4. Infection near the radial artery puncture site
5. Congenital heart disease
6. Patients who had undergone arterial puncture within the 1-month period immediately preceding the commencement of the trial.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the success rate of first attempt cannulation using the two methods. |
Immediately after cannulation approximately 5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the total Cannulation time using the two methods. |
time taken for successful cannulation approximately 5 minute duration |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
16/12/2021 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
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 commonly performed in the operating room for invasive arterial pressure monitoring and arterial blood gas analysis. Radial artery cannulation is traditionally performed by anatomic landmark and palpation of radial pulse. Multiple attempts attributable to failure of cannulation may lead to an arterial hepatoma formation on anatomic land mark technique. Ultrasound guided radial artery cannulation help in first attempt success rate. We assume that the help of acoustic shadow on ultrasound may further improve further improve success rate and reduce timing in radial artery cannulation |