| CTRI Number |
CTRI/2025/07/090896 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the time taken for Internal Jugular Vein cannulation by two different techniques via posterior approach in patients undergoing cardiac surgeries. |
|
Scientific Title of Study
|
A Randomized Comparative Study Of IJV Cannulation By Anatomical Landmark Technique Versus USG Guided Technique Via Posterior Approach At S.M.S. 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 Reema Meena |
| Designation |
Senior Professor |
| Affiliation |
Sawai Mansingh Medical College, Jaipur |
| Address |
Department of Anaesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur, Rajasthan.
Jaipur
RAJASTHAN
302001
India |
| Phone |
9413237117 |
| Fax |
|
| Email |
reemadr.rn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reema Meena |
| Designation |
Senior Professor |
| Affiliation |
Sawai Mansingh Medical College, Jaipur |
| Address |
Department of Anaesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur, Rajasthan.
Jaipur
RAJASTHAN
302001
India |
| Phone |
9413237117 |
| Fax |
|
| Email |
reemadr.rn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Singh |
| Designation |
PG Student |
| Affiliation |
Sawai Mansingh Medical College, Jaipur |
| Address |
Department of Anaesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur, Rajasthan.
Jaipur
RAJASTHAN
302001
India |
| Phone |
7568998621 |
| Fax |
|
| Email |
swatisingh1142@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, SMS Medical College, Jaipur, Rajasthan, India-302001 |
|
|
Primary Sponsor
|
| Name |
Sawai Mansingh Medical College and Hospital |
| Address |
Department of Anaesthesiology, Second Floor, OT Complex, Dhanwantri Building, SMS Hospital , Jaipur. |
| 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 Reema Meena |
SMS Medical College and Hospital |
Department of Anaesthesiology, Second Floor, Dhanwantri Building, SMS Hospital, JLN Marg, Jaipur, Rajasthan.
Jaipur
RAJASTHAN |
09413237117
reemadr.rn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Ethics Committee, SMS Medical College And Attached Hospitals, Jaipur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A= Conventional anatomical landmark technique will be used for IJV cannulation via posterior approach. |
The point where external jugular vein crosses the posterolateral border of sternocleidomastoid is the entry point. A skin wheal will be raised at this point with 1 ml of 2% lignocaine. The body of the muscle will be lifted and an 18G introducer needle will be then advanced at an angle of 30 degrees to the skin, directed towards the suprasternal notch. With constant aspiration the needle will be slowly advanced until two tissue pops are felt at the prevertebral fascia and the vein wall. The position of the vein will be confirmed by the aspiration of dark blood. The vein will be cannulated by modified Seldingers technique. The hub of the cannula will be anchored with sutures. |
| Intervention |
Group B= USG guided technique will be used for IJV cannulation via posterior approach. |
The patient will be placed in Trendlenburg position, with head slightly rotated to the contralateral side. Using USG probe, the anatomical location and patency of the IJV will be assessed and guided by real-time USG imaging, the introducer needle mounted on a syringe will be inserted into the IJV. Once blood is freely aspirated, the USG probe will be set aside and the syringe is removed from the needle. The procedure is further completed as mentioned in conventional anatomical landmark technique and various variables are noted. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients giving informed written consent.
2. Patients of either gender of age 18 years and above scheduled for elective cardiac surgery.
3. Subjects with ASA grade 2 to 3. |
|
| ExclusionCriteria |
| Details |
1. Patients taking part in any other study.
2. Patients with prior neck surgery.
3. Patients with suspected cervical spine injury.
4. Patients with penetrative injury to neck or head and neck cancer patients.
5. Patients with coagulopathies.
6. Patients with BMI more than 30.
7. Patients with local site infections and burns. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the first attempt success rate of IJV cannulation between the two groups. |
First attempt sucess rate will be assessed at baseline for the two techniques. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess & compare the difference in number of attempts taken for IJV cannulation between the two groups.
2.To assess & compare the overall success rate of IJV cannulation between the two groups.
3.To determine the difference in flash time, cannulation time & total procedure time.
4.To assess & compare the incidence of procedure related complications between the two groups. |
1.Number of attempts taken at baseline.
2.Skin puncture to blood falshback time in seconds at baseline.
3.Blood flashback to catheter insertion time in seconds at baseline.
4.Total procedure time in seconds at baseline.
5.Complications if any, such as, hematoma formation, posterior wall puncture, carotid artery puncture will be noted at baseline. |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 |
|
Date of First Enrollment (India)
|
28/07/2025 |
| 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 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
|
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Brief Summary
|
Central venous cannulation is a very commonly performed procedure in perioperative period and ICUs. The common vessels used are Internal Jugular Vein, Femoral Vein and Subclavian Vein. Three approaches can be used for IJV cannulation namely, Anterior, Central and Posterior. Central approach is the most commonly used but comparatively Posterior approach is found to be significantly better in prevention of complications. The IJV cannulation will be done via Posterior approach comparing two techniques- Anatomical landmark based technique versus USG guided technique. Patient is taken in OT. NBM status, PAC, written and informed consent will be checked. Patient demographic data are taken like age, sex, BMI,NIBP. Routine vital monitors are attached for ECG, SpO2, EtCO2, Entropy, Peripheral IV line. After randomization patients will be allocated in two groups. Baseline characteristics are noted such as HR,SBP,DBP,MBP(invasive). IJV cannulation via posterior approach will be done by conventional anatomical landmark method or USG guided method. Variables will be noted such as first attempt success rate, number of attempts, skin puncture to flashback time, flashback to catheter insertion time, total procedure time. Complications if any such as posterior wall puncture, carotid artery puncture, hematoma formation are noted. Statistical analysis is done using appropriate tests and software and conclusions are drawn.
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