| CTRI Number |
CTRI/2024/08/072459 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of infraclavicular subclavian vein catheterisation under ultrasound guidance versus landmark technique- a prospective observational study. |
|
Scientific Title of Study
|
A prospective observational study of Comparison of infraclavicular subclavian vein catheterisation under ultrasound guidance versus landmark technique in tertiary care centre-A prospective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arun G |
| Designation |
Post Graduate student |
| Affiliation |
Sree Balaji Medical College and Hospital, Chennai |
| Address |
Department of anaesthesia,3rd floor,Sree Balaji medical college and Hospital no.7,clc works road Chromepet Chennai 600044,Chennai,tamilnadu,600044, India.
Chennai
TAMIL NADU
600117
India |
| Phone |
9790236392 |
| Fax |
|
| Email |
arundoc07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Raghuraman |
| Designation |
Head of the Department, Anaesthesia |
| Affiliation |
Sree Balaji Medical College and Hospital |
| Address |
Department of anaesthesia,3rd floor,Sree Balaji medical college and Hospital no.7,clc works road Chromepet Chennai 600044,Chennai,tamilnadu,600044, India
Chennai
TAMIL NADU
600044
India |
| Phone |
6379141854 |
| Fax |
|
| Email |
anaesth123sbm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Raghuraman |
| Designation |
Head of the Department, Anaesthesia |
| Affiliation |
Sree Balaji Medical College and Hospital |
| Address |
Department of anaesthesia,3rd floor,Sree Balaji medical college and Hospital no.7,clc works road Chromepet Chennai 600044,Chennai,tamilnadu,600044, India
TAMIL NADU
600044
India |
| Phone |
6379141854 |
| Fax |
|
| Email |
anaesth123sbm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia,3rd floor,Sree Balaji medical college and Hospital no.7,clc works road Chromepet Chennai 600044,Chennai,tamilnadu,600044,India |
|
|
Primary Sponsor
|
| Name |
Dr raghuraman |
| Address |
Department of anaesthesia,3rd floor,Sree Balaji medical college and Hospital no.7,clc works road Chromepet Chennai 600044,Chennai,tamilnadu,600044, India.
|
| Type of Sponsor |
Private medical college |
|
|
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 Arun G |
Sree Balaji medical college and hospitals |
Department of anaesthesia,3rd floor,Sree Balaji medical college and Hospital no.7,clc works road Chromepet Chennai 600044,Chennai,tamilnadu,600044,India
Chennai
TAMIL NADU |
9790236392
arundoc07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sree Balaji medical college and hospital,INSTITUTIONAL HUMAN ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-70 years
Either sex
ASA PS I,II,III
BMI<30 |
|
| ExclusionCriteria |
| Details |
Controlateral pneumothorax/hemothorax
Recent trauma or infection at procedure site,spine deformity,pregnant women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The first pass success rate of subclavian catheterization under ultrasound guidance is better than landmark technique |
Base line |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of attempts is lesser in ultrasound guided subclavian catheterization than landmark technique |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
25/08/2024 |
| 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="0"
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
|
Central venous cannulation plays a vital role in intensive care units for critically ill patients, volume resuscitation, central venous pressure monitoring, transverse cardiac pacing, hemodialysis access in the operating theatre, as a part of everyday medical practice. internal jugular vein, subclavian vein and femoral vein is commonly selected for central vein cannulation. depending on preference of physician, ease of access, coagulation status, infection and various complication rate. subclavian vein have several advantages of large diameter, absence of valve, ability to remain patent and relatively constant position and carries low risk of catheter related infection and thrombosis. then femoral and internal jugular vein. |