| CTRI Number |
CTRI/2025/12/098305 [Registered on: 02/12/2025] Trial Registered Prospectively |
| Last Modified On: |
07/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Two Methods for Safely Inserting a central line into a Neck Vein Using Ultrasound in ICU Patients |
|
Scientific Title of Study
|
Comparative study of efficacy and safety between long axis in-plane versus short axis out-plane approaches for ultrasound guided Internal Jugular Vein Cannulation in ICU- Comparative 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 |
Aniket Kalariya |
| Designation |
Resident Doctor |
| Affiliation |
S.B.K.S MEDICAL INSTITUTE AND RESEARCH CENTRE, SUMANDEEP VIDYAPEETH UNIVERSITY |
| Address |
Department of Anaesthesiology, General O.T. Complex, 2nd floor, Dhiraj Hospital,
S.B.K.S Medical Institute and Research Centre, Sumandeep Vidyapeeth University, Piparia, Waghodia,
Vadodara 391760 Gujarat, INDIA
Department of Anaesthesiology, General O.T. Complex, 2nd floor, Dhiraj Hospital,
S.B.K.S Medical Institute and Research Centre, Sumandeep Vidyapeeth University, Piparia, Waghodia,
Vadodara 391760 Gujarat, INDIA
Vadodara
GUJARAT
391760
India |
| Phone |
08128013366 |
| Fax |
|
| Email |
aniketkalariya018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Chauhan |
| Designation |
Professor |
| Affiliation |
S.B.K.S Medical Institute and Research Centre, Sumandeep Vidyapeeth Deemed to be University |
| Address |
Department of Anaesthesiology, General O.T. Complex, 2nd floor, Dhiraj Hospital,
S.B.K.S Medical Institute and Research Centre, Sumandeep Vidyapeeth University, Piparia, Waghodia,
Vadodara 391760 Gujarat, INDIA
Department of Anaesthesiology, General O.T. Complex, 2nd floor, Dhiraj Hospital,
S.B.K.S Medical Institute and Research Centre, Sumandeep Vidyapeeth University, Piparia, Waghodia,
Vadodara 391760 Gujarat, INDIA
Vadodara
GUJARAT
391760
India |
| Phone |
9426368170 |
| Fax |
|
| Email |
dramitchauhan85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Chauhan |
| Designation |
Professor |
| Affiliation |
S.B.K.S Medical Institute and Research Centre, Sumandeep Vidyapeeth Deemed to be University |
| Address |
Department of Anaesthesiology, General O.T. Complex, 2nd floor, Dhiraj Hospital,
S.B.K.S Medical Institute and Research Centre, Sumandeep Vidyapeeth University, Piparia, Waghodia,
Vadodara 391760 Gujarat, INDIA
Department of Anaesthesiology, General O.T. Complex, 2nd floor, Dhiraj Hospital,
S.B.K.S Medical Institute and Research Centre, Sumandeep Vidyapeeth University, Piparia, Waghodia,
Vadodara 391760 Gujarat, INDIA
Vadodara
GUJARAT
391760
India |
| Phone |
9426368170 |
| Fax |
|
| Email |
dramitchauhan85@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SBKS Medical Institute and Research Centre |
| Address |
Piparia, Waghodia, Vadodara, Gujarat, India - 391760 |
| 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 Amit Chauhan |
S.B.K.S Medical Institute and Research Centre, Sumandeep Vidyapeeth Deemed to be University |
Department of Anaesthesiology, General O.T. Complex, 2nd floor, Dhiraj Hospital,
S.B.K.S Medical Institute and Research Centre, Sumandeep Vidyapeeth University, Piparia, Waghodia,
Vadodara 391760 Gujarat, INDIA
Vadodara
GUJARAT |
09426368170
dramitchauhan85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J989||Respiratory disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IJV cannulation under ultra sound guidance in Long Axis- In-Plane mode |
IJV cannulation under ultra sound guidance in Long Axis- In-Plane mode-In the LA approach, the entire length and the tip of the needle can be seen, but it is technically challenging in part that the needle and US beam should be perfectly aligned. The entire procedure may last upto 20 minutes |
| Comparator Agent |
IJV cannulation under ultra sound guidance in Short Axis- out of plane mode |
IJV cannulation under ultra sound guidance in Short Axis- out of plane mode-the SA approach allows us to view the artery and vein. simultaneously, we cannot see the needle’s whole length or tip.
The entire procedure may last upto 20 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to sign informed consent
2. Male or Female patients between 18 to 60 years of age
3. Patients who need IJV cannulation in ICU
|
|
| ExclusionCriteria |
| Details |
1. Patients unwilling to participate in study.
2. Patients with local site infection
3. Patients with untreated coagulopathy
4. Psychiatric patients
5. Pregnancy and lactating women
6. Patients with possible abnormal structures in the neck
7. Recent cervical trauma
8. History of IJV catheterisation in past 1 month.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This prospective and observational study will help us to compare the efficacy and safety between long-axis in-plane vs short-axis Out-of-plane approaches for Ultrasound guided Internal Jugular Vein Cannulation in ICU. |
baseline
Pre Procedure
1 minute after procedure
3 minute after procedure
5 minute after procedure
10 minute after procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
observation of complications after inseertion of central line like - Bradycardia Hypotension Arrythmias Persistent hypertension
|
pre procedure, baseline and after 1,3,5,10 minutes |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
12/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/12/2025 |
| 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)
|
Open to Recruitment |
| 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
Modification(s)
|
This study aims to compare the efficacy and safety between long axis in plane versus short axis out plane approaches for ultrasound guided internal jugular vein cannulation in ICU patients. In long asis plane- the tip and end of the needle can be seen but it is technically challenging whereas in short axis plane - we can view the artery and vein simultaneously but the needles length and tip is not vissible. This brings us to the need of the study. |