| CTRI Number |
CTRI/2025/05/087629 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
21/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparing two ultrasound techniques for safer neck vein cannulation in surgical patients by reducing posterior wall puncture and improving accuracy |
|
Scientific Title of Study
|
A randomized comparative study to evaluate the scan-as-you-go technique versus short axis out-of-plane technique on the incidence of posterior venous wall puncture in ultrasound guided internal jugular vein cannulation Department of Anaesthesia in 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 |
| Address |
Department of Anaesthesia Sawai Man Singh Medical College and attached hospitals Jawahar Lal Nehru Marg, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan
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 |
| Address |
Department of Anaesthesia Sawai Man Singh Medical College and attached hospitals Jawahar Lal Nehru Marg, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9413416787 |
| Fax |
|
| Email |
poonamkalra24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mudrika Pareek |
| Designation |
Junior Resident |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Anaesthesia Sawai Man Singh Medical College and attached hospitals Jawahar Lal Nehru Marg, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
7412999930 |
| Fax |
|
| Email |
drmudrikapareek@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sawai man singh medical college and attached hospitals Jawahar Lal Nehru Marg, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan ,India 302004 |
|
|
Primary Sponsor
|
| Name |
Sawai man singh medical college |
| Address |
Department of Anaesthesia Sawai Man Singh Medical College and attached hospitals Jawahar Lal Nehru Marg, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan ,India 302004 |
| 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 Poonam kalra |
Sawai man singh medical college and attached hospitals |
Gastro and hepatic surgery operation theatre ,department of anesthesiology
Jaipur
RAJASTHAN |
09413416787
poonamkalra24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee sms medical college and attached hospitals jaipur |
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 |
Scan as yo go technique |
The scan-as-you-go technique (SAYGO) combines the techniques of dynamic needle tip visualization in the short axis out of plane ( SAOP)
and long axis in-plane while entering the anterior venous wall to reduce the incidence of posterior venous wall puncture ( PVWP).Duration 15 min timing and parameters assess only one time after successful intervention.
|
| Comparator Agent |
Short axis out of plane technique |
The short-axis approach (SAX) allows simultaneous visualization of
both artery and vein but can make needle tip control difficult.Duration 15 min timing and parameters assess only one time after successful intervention.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of either sex scheduled for any elective surgery or emergency case in OT.
Patients of ASA grade 1 ,2 and 3. |
|
| ExclusionCriteria |
| Details |
Patients not providing consent
Any surgical intervention at cannulation site
Present or past history of neck mass
Limited neck mobility
Patients with infection , burn , trauma or subcutaneous hematoma close to puncture site
Any coagulopathy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of cases of posterior venous wall puncture |
15 min.
Timing and parameters assess only one time after successful intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean number of attempts for successful cannulation .
Mean Time taken from needle insertion to free aspiration of blood.
Mean Time taken for successful guide wire placement.
Mean Time taken for successful cannulation.
Proportion of cases with complication (if any).
|
15 min.
Timing & parameters assess only one time after successful intervention. |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
15/06/2025 |
| 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="3"
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
|
title - A comparative study of the scan as yo go versus short axis out of pane technique on the posterior venous wall puncture in ultrasound guided internal jugular vein cannulation
this randomised controlled study aimed to compare the incidence of posterior venous wall puncture between scan as yo go technique that combines the techniques of dynamic needle tip visualization in the short axis out of plane and long axis in plane while entering the anterior venous wall with the traditional short axis out of plane approach which allows simultaneous visualization of the artery and vein during ultrasound guided internal jugular vein cannulation . a total of 128 patients were randomly allocated into groups and along with posterior venous wall puncture number of attempts tike take for insertion to free aspiration of blood time take for successful guide wire placement time taken for successful cannulation and complication if any will be noted and compared though the scan as you go technique offers improved safety with reduced risk of posterior wall puncture , making it a valuable technique in the clinical practice |