| CTRI Number |
CTRI/2024/04/066478 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
11/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparision of the conventional and a novel technique for radial artery cannulation. |
|
Scientific Title of Study
|
A comparision of radial artery cannulation by fixed angle (conventional switch cannula) technique versus variable angle (SK-TRAC) technique. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Urvashi Rathi |
| Designation |
Junior Resident |
| Affiliation |
Command Hospital Air Force |
| Address |
Department of Anaesthesiology and Critical Care, Command Hospital Air Force, Agram Post , Bangalore
Bangalore
KARNATAKA
560007
India |
| Phone |
9354994417 |
| Fax |
|
| Email |
urvashirathi36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Satish Kumar Mishra |
| Designation |
Professor |
| Affiliation |
Command Hospital Air Force |
| Address |
Department of Anaesthesiology and Critical Care, Command Hospital Air Force, Agram Post , Bangalore
Bangalore
KARNATAKA
560007
India |
| Phone |
7829024442 |
| Fax |
|
| Email |
mdsatish08@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Paridhi S Gupta |
| Designation |
Senior Resident |
| Affiliation |
Command Hospital Air Force |
| Address |
Department of Anaesthesiology and Critical Care, Command Hospital Air Force, Agram Post , Bangalore
Bangalore
KARNATAKA
560007
India |
| Phone |
9407500837 |
| Fax |
|
| Email |
paridhis1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Commandant, Command Hospital Airforce,Agram Post, Bengalore, Karnataka, India 560007 |
|
|
Primary Sponsor
|
| Name |
Commandant Command Hospital Air Force Agram Post Bangalore |
| Address |
Department of Anaesthesiology and Critical Care, Command Hospital Air Force, Agram Post , Bangalore (560007) |
| 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 Urvashi Rathi |
Command Hospital Air Force, Bengalore |
Department of Anaesthesiology and Critical Care, Command Hospital Air Force, Agram Post , Bangalore, karnataka 560007
Bangalore
KARNATAKA |
9354994417
urvashirathi36@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Command Hospital Air Force Bengalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I051||Rheumatic mitral insufficiency, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients requiring invasive arterial pressure monitoring or repeated arterial blood gas analysis. |
|
| ExclusionCriteria |
| Details |
patients with local skin infection or history of vascular graft in concerned upper limb. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the rate of successful cannulation using both the techniques. |
Successful cannulation within 05 minutes and complications within 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| total time taken and total number of attempts for successfull cannulation. |
15 min |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/06/2024 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The data will be collected using a predesigned template which will be filled by the concerned physician involved in the immediate treatment of the patient. The collected data variables obtained will be compiled by using an excel spreadsheet. The baseline patient characteristics are presented as frequencies for the categorical variables and as the means and standard deviations or medians and inter-quartile ranges for continuous variables. After appropriate data filtration, the data sheet will be transferred and analyzed using Statistical Package for Social Sciences (SPSS vs. 22.0). Comparison of quantitative variables between the study groups will be done by using Student t-test and One-way Analysis of Variance (ANOVA) test for independent samples for parametric and non-parametric data respectively. For comparing categorical data, Chi square (χ2) test or fishers exact test will be performed. Binary logistic regression will be conducted to ascertain significant predictors for successful cannulation. |