| CTRI Number |
CTRI/2024/01/061180 [Registered on: 08/01/2024] Trial Registered Prospectively |
| Last Modified On: |
03/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
This study is intended to find out whether short axis or long axis of ultrasound is better for internal jugular vein cannulation in terms of time required |
|
Scientific Title of Study
|
A prospective randomised observational study to compare time required for cannulation using short axis versus long axis approach for ultrasound guided internal jugular vein cannulation for central venous access in department of Anaesthesia,SMS Medical College, Jaipur |
| 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 Poonam Kalra |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospitals |
| Address |
Department of Anesthesiology, Sawai Man Singh Medical College and Attached Hospitals, Adarsh Nagar, Jaipur, RAJASTHAN 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9413416787 |
| Fax |
|
| Email |
poonamkalra24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Kalra |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospitals |
| Address |
Department of Anesthesiology,Sawai Man Singh Medical College and Attached Hospitals, Adarsh Nagar, Jaipur,Rajasthan
Jaipur, RAJASTHAN 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9413416787 |
| Fax |
|
| Email |
poonamkalra24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lakshmi Raj V |
| Designation |
Junior Resident |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospitals |
| Address |
Department of Anesthesiology, Sawai Man Singh Medical College and Attached Hospitals, Adarsh Nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
6238010532 |
| Fax |
|
| Email |
lakshmiraj275@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Sawai Man Singh Medical College and Attached Hospitals,Jaipur |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology, S.M.S And Attached Groups of Hospitals |
| Address |
Department of Anesthesiology, Second floor, Dhanvantri complex S.M.S Medical College, Jaipur, Rajasthan |
| Type of Sponsor |
Government 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 Lakshmi Raj V |
SMS Medical College and Attached Hospitals |
Department of Anaesthesiology, Second floor,Dhanwantari Complex, S.M.S Medical College and Attached Group of Hospitals,JLN Marg ,Adarsh Nagar ,Jaipur
Jaipur
RAJASTHAN |
6238010532
lakshmiraj275@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS MEDICAL COLLEGE 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
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients of either sex scheduled for any elective surgery or admitted in ICU requiring IJV cannulation
2. Age 18 years to 55 years
3. Patients of ASA grade 1 and 2.
|
|
| ExclusionCriteria |
| Details |
1.Patients not providing consent
2. Any surgical intervention at cannulation site
3. Present or past history of neck mass
4.Diagnosis of SVC syndrome
5.Limited neck mobility
6.Patients with infection or subcutaneous hematoma close to puncture site
7.History of internal jugular vein cannulation within last 72 hours at same site
8.Severe coagulopathy and internal jugular vein thrombus
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Mean Catheterization time of internal jugular vein
2.Mean Venous access time of internal jugular vein
3.Mean Guide Wire time
4.Mean number of needle passes
5.Proportion of Success of cannulation of internal jugular vein |
Taking needle prick time as 0seconds ,outcome of internal jugular vein cannulation is recorded |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complications like carotid artery puncture, pneumothorax, hematoma formation, arrhythmias and any catheter malposition. |
During and after internal jugular vein cannulation |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
14/01/2024 |
| 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="0"
Months="3"
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
|
In this study our aim is to compare short axis versus long axis approach for ultrasound guided internal
jugular vein cannulation and to find out which
scanning axis provides optimal condition for vascular access.
|