| CTRI Number |
CTRI/2025/03/083418 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Other (Specify) [central venous catheter insertion] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the time taken and complications observed during left internal jugular vein cannulation by landmark vs ultrasound |
|
Scientific Title of Study
|
THE COMPARATIVE STUDY OF LEFT INTERNAL JUGULAR VEIN CANNULATION BY REAL TIME ULTRASOUND IMAGING V/S ANATOMICAL LANDMARK TECHNIQUE: A PROSPECTIVE RANDOMIZED 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 |
Dr Ravi Paul singh |
| Designation |
Associate professor |
| Affiliation |
Government medical college |
| Address |
department of anaesthesia and critical care
Government medical college
Circular road
Amritsar
department of anaesthesia and critical care
Government medical college, circular road
amritsar,143001
punjab
Amritsar
PUNJAB
143001
India |
| Phone |
9815159370 |
| Fax |
|
| Email |
71ahuja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Paul singh |
| Designation |
Associate professor |
| Affiliation |
Government medical college,amritsar |
| Address |
department of anaesthesia and critical care
Government medical college
Circular road
Amritsar
department of anaesthesia and critical care
Government medical college, circular road amritsar 143001
punjab
Amritsar
PUNJAB
143001
India |
| Phone |
9815159370 |
| Fax |
|
| Email |
71ahuja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi Paul singh |
| Designation |
Associate professor |
| Affiliation |
Government medical college,amritsar |
| Address |
department of anaesthesia and critical care
Government medical college
Circular road
Amritsar
department of anaesthesia and critical care
Government medical college, circular road,amritsar
punjab
143001
Amritsar
PUNJAB
143001
India |
| Phone |
9815159370 |
| Fax |
|
| Email |
71ahuja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college, Amritsar |
|
|
Primary Sponsor
|
| Name |
Dr Ravi Paul singh |
| Address |
Department of anaesthesiology and critical care
Government medical college, Amritsar |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Leena Mahajan |
Department of anaesthesiology and critical care
Government medical college, Amritsar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Akansha Sardana |
Government medical college |
ICU
Department of Anaesthesia and Critical care
Amritsar
PUNJAB |
9885393315
akanshasardana01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, Government medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
THE STUDY OF LEFT INTERNAL JUGULAR VEIN CANNULATION BY REAL TIME ULTRASOUND IMAGING |
we will insert central line in left internal jugular vein by using ultrasound guidance.we observe for the time taken for insertion and any complications related to it for the next 24 hours. |
| Comparator Agent |
THE STUDY OF LEFT INTERNAL JUGULAR VEIN CANNULATION BY ANATOMICAL LANDMARK TECHNIQUE |
we will insert central line in left internal jugular vein by using anatomical landmarks. we observe for the time taken for insertion and any complications related to it for the next 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA Grade 1, 2 and 3
2. Patients in whom the Right IJV cannot be cannulated due to presence of thrombus, infective foci, significantly stenosis or due to previous surgery on the right side. |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Patient with unstable neck injuries
3.Thrombocytopenia
4.Coagulopathy
5.Local infection
6.Raised intracranial pressure
7.Patient non-compliance |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The total access time, which is the time taken from initial skin puncture to
proper placement of the guidewire into the vein.
2.The number of attempts required to successfully cannulate the IJV |
Time from start of procedure till successful placement of central venous catheter. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compare the two methods with respect to:
1.The success rate
2.The side effects
3.Haemodynamic parameters |
Time from start of procedure till 24 hours post procedure |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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)
|
Not Yet Recruiting |
| 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
|
This study is prospective randomized parallel group trial comparing left internal jugular vein cannulation by real time ultrasound imaging versus anatomical landmark technique. The study will be conducted in government medical college, amritsar,on 60 patients of either sex in the age group of 18-60 years, randomly divided into two groups of 30 patients each .In one group left internal jugular vein will be cannulated by real time ultrasound imaging and in the second group left internal jugular vein will be cannulated by anatomical landmark technique .The data thus obtained will be analyzed and compared statistically. |