| CTRI Number |
CTRI/2024/06/068333 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of two sites of radial artery cannulation. |
|
Scientific Title of Study
|
Comparision of two sites of radial artery cannulation at the wrist of adult surgical patients in
terms of first attempt success rate of cannulation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nithyaviknesh kumar |
| Designation |
Resident |
| Affiliation |
sri ramachandra institue of higher education and research center |
| Address |
PG resident,department of anesthesiology,Sri Ramachandra University,Porur,chennai-60011
Chennai
TAMIL NADU
600020
India |
| Phone |
9445566588 |
| Fax |
|
| Email |
nithya.vikneshkumar2016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venkatesh S |
| Designation |
Professor |
| Affiliation |
sri ramachandra institue of higher education and research hospital |
| Address |
Professor, department of anesthesiology,Sri Ramachandra University, Porur, chennai-600116.
Thiruvallur
TAMIL NADU
600056
India |
| Phone |
9944731220 |
| Fax |
|
| Email |
venkymail2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Venkatesh S |
| Designation |
Professor |
| Affiliation |
sri ramachandra institue of higher education and research hospital |
| Address |
Professor, department of anesthesiology,Sri Ramachandra University, Porur, chennai-600116.
Thiruvallur
TAMIL NADU
600056
India |
| Phone |
9944731220 |
| Fax |
|
| Email |
venkymail2014@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri ramachandra medical college and research hospita,porur,chennai-600116 |
|
|
Primary Sponsor
|
| Name |
Sri ramachandra institute of higher education and research hospital |
| Address |
Sri ramachandra university porur,chennai-600116 |
| 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 Nihyaviknesh kumar |
Sri ramachandra institute of higher education and research hospital |
Or complex,aneshesiology department,sriher,porur,chennai600116,thiruvalur,tamilnadu
Thiruvallur
TAMIL NADU |
9445566588
nithya.vikneshkumar2016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee- Sri Ramachandra University ( IEC-SRU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I248||Other forms of acute ischemic heart disease, (2) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparing radial artery cannulation at two sites of wrist |
Comparing radial artery cannulation at wrist crease and 2 cm from the wrist crease proximally |
| Intervention |
Comparision of two sites of radial artery cannulation. |
Comparision of two sites of radial artery cannulation at the wrist of adult surgical patients in terms of first attempt success rate of cannulation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of either gender of asa 2 and above requiring invasive blood pressure monitoring. |
|
| ExclusionCriteria |
| Details |
Paient refusal
Infection at puncture site
Hisory of peripheral vascular disease
Coagulopathy
Modified allens est showing negative for collateral flow |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| First attempt success rate |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time taken for cannulation
Difficulty in cannulation after multiple attempts
Pain after cannulation
Duration of pain
Presence of pulsation at puncture site after 24 hours of removal |
At baseline after 24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/06/2024 |
| Date of Study Completion (India) |
21/03/2025 |
| Date of First Enrollment (Global) |
10/06/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Intra arterial cannulation for continuous beat to beat pressure monioring.Comparing the two sites for access a he wrist for radial artery cannulation and seeing the first attempt success rate and risk of complication between 2 points |