| CTRI Number |
CTRI/2025/09/093970 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
31/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Making Central Line Insertion Safer: The Role of a Needle Guard |
|
Scientific Title of Study
|
A randomized comparative study to evaluate the efficacy of ultrasound guided internal jugular vein cannulation in short axis approach using needle with a guard versus without a guard 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 |
Poonam Kalra |
| Designation |
Senior professor |
| Affiliation |
SMS MEDICAL COLLEGE Jaipur |
| Address |
Department of Anaesthesia
Sms medical college
And Attached hospitals
Jaipur
Rajasthan
Department of anaesthesia SMS medical college Jaipur
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 |
SMS Medical College Jaipur |
| Address |
Department of anaesthesia
SMS Medical College
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9413416787 |
| Fax |
|
| Email |
poonamkalra24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Kalra |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Department of anaesthesia
SMS Medical College
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9413416787 |
| Fax |
|
| Email |
poonamkalra24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia SMS medical college and hospitals Jaipur |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesia SMS medical college and attached hospital Jaipur |
| Address |
Department of anaesthesia SMS medical college and attached hospital Jaipur Rajasthan 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 Divya gupta |
SMS Medical college Jaipur |
Department of anaesthesia
SMS
Jaipur Rajasthan
302004
302004
Jaipur
RAJASTHAN |
7597404501
divyagupta1205@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of ethics committee SMS Medical College Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (2) ICD-10 Condition: K77||Liver disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
The intervention in the study is the use of a needle fitted with a specially designed guard during ultrasound guided internal jugular vein cannulation. |
The intervention involves the use of a specially designed needle with a guard during ultrasound guided internal jugular vein cannulation. The guard is a non PVC disc with a central hole that fits snugly over the needle shaft and is adjusted to a length equal to the distance from the skin surface to the midpoint of the internal jugular vein, as measured by ultrasound. This guard limits the depth of needle penetration to prevent inadvertent puncture beyond the vein, thereby reducing complications such as posterior venous wall puncture. The procedure uses a short axis ultrasound approach with the needle inserted at a 45 degree angle under ultrasound guidance, confirmed by blood aspiration and imaging. |
| Comparator Agent |
Use of a standard needle without any guard during ultrasound guided internal jugular vein cannulation. |
This involves performing the procedure using the conventional needle without any modification to limit needle penetration depth. The cannulation is done using the short axis ultrasound guided approach with the needle inserted at a 45 degree angle, and successful vein entry is confirmed by ultrasound imaging and blood aspiration. This represents the current standard practice against which the needle with guard intervention is compared. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of either sex scheduled for any elective surgery requiring internal jugular vein (IJV) cannulation.
Patients willing to provide informed consent.
Patients classified as American Society of Anesthesiologists (ASA) grade 1, 2, or 3.
Patient age between 19 and 65 years. |
|
| ExclusionCriteria |
| Details |
Any surgical intervention at the cannulation site.
Present or past history of neck mass.
Limited neck mobility.
Patients with infection, burn, trauma, or subcutaneous hematoma close to the puncture site.
Infection or phlebitis at the site of insertion.
Patients with body mass index (BMI) greater than 35 kg/m².
Coagulopathy and internal jugular vein thrombus. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Number of attempts for successful internal jugular vein (IJV) cannulation between both groups.
Incidence of posterior venous wall puncture between both groups. |
All outcomes were measured intra procedurally or immediately postprocedure.
No long term or follow up assessment time points were specified. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ease of cannulation between both groups which was based on operator satisfaction rating |
All secondary outcomes were evaluated intra procedurally during the cannulation procedure & & immediately post procedure before the patient left the operating or procedure area. |
| Incidence of accidental common carotid artery puncture between both groups. |
|
| Incidence of various anatomical relationships of the internal jugular vein with respect to common carotid artery between the two groups. |
|
| Correlation of anatomical variation in relationship of IJV with respect to CCA in cases of accidental common carotid puncture between the two groups. |
|
| Other complications such as pneumothorax, vertebral artery puncture, and damage to other important structures of the neck between both groups. |
|
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
15/09/2025 |
| 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="4"
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
|
This is a prospective, randomized controlled trial conducted at the Department of Anaesthesia, SMS Medical College, Jaipur, aiming to evaluate the effectiveness and safety of using a needle with a guard versus a needle without a guard during ultrasound-guided internal jugular vein (IJV) cannulation using a short axis approach. The primary focus is to compare the success rate, particularly the number of attempts for successful cannulation and the incidence of posterior venous wall puncture between the two groups. Secondary outcomes include assessing the ease of cannulation, incidence of accidental common carotid artery puncture, anatomical variations of the IJV in relation to the carotid artery, and other complications like pneumothorax or hematoma. The study uses computer generated randomization to allocate 150 patients equally into two groups (with and without needle guard) and it is single blinded, with patients blinded to the needle type. The intervention involves utilising a specially designed non-PVC disc guard on the needle to limit its depth, potentially reducing complications associated with deep needle penetration. The study sample size is based on achieving 80% power and 5% significance, accounting for a 10% dropout rate. This trial seeks to provide evidence on whether using a guard improves the safety and efficiency of ultrasound-guided IJV cannulation compared with the conventional needle technique without a guard. |