| CTRI Number |
CTRI/2026/03/106704 [Registered on: 23/03/2026] Trial Registered Prospectively |
| Last Modified On: |
22/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two approaches of inserting a tube called central line into one of the large vein in the neck called subclavian vein under ultrasound guidance in terms of first attempt success rate. |
|
Scientific Title of Study
|
Comparison of Supraclavicular Anterior Out-of-plane Approach with Infraclavicular Out-of-plane Approach for Ultrasound guided Subclavian Vein Cannulation: A Prospective Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JAYALAKSHMI R |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE , 2nd floor institute building , JIPMER CAMPUS ,GORIMEDU , DHANVANTARI NAGAR , PUDUCHERRY
Pondicherry PONDICHERRY 605006 India |
| Phone |
9597631212 |
| Fax |
|
| Email |
jayakavya111@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
JAYANTH R SESHAN |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE , 2nd floor institute building , JIPMER CAMPUS ,GORIMEDU , DHANVANTARI NAGAR , PUDUCHERRY
Pondicherry PONDICHERRY 605006 India |
| Phone |
8424017925 |
| Fax |
|
| Email |
drrjayanth.seshan@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
JAYANTH R SESHAN |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE , 2nd floor institute building , JIPMER CAMPUS ,GORIMEDU , DHANVANTARI NAGAR , PUDUCHERRY
PONDICHERRY 605006 India |
| Phone |
8424017925 |
| Fax |
|
| Email |
drrjayanth.seshan@gmail.com |
|
|
Source of Monetary or Material Support
|
| JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH ( Intramural fund) |
|
|
Primary Sponsor
|
| Name |
JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH |
| Address |
JIPMER campus road , Gorimedu , Dhanvantari nagar ,Pondicherry 605005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| JAYALAKSHMI R |
JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE , JIPMER CAMPUS ,GORIMEDU , DHANVANTARI NAGAR , PUDUCHERRY Pondicherry PONDICHERRY |
09597631212
jayakavya111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER Institutional ethics committee for interventional studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z452||Encounter for adjustment and management of vascular access device, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Infraclavicular subclavian vein cannulation |
The subclavian vein will be cannulated via the infraclavicular out of plane approach in patients requiring central venous access |
| Intervention |
Supraclavicular subclavian vein cannulation |
The subclavian vein will be cannulated via the supraclavicular anterior out of plane approach in patients requiring central venous access. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients over 18 years of age admitted in JIPMER for elective surgeries requiring a central venous access in perioperative period. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the first pass success rate of supraclavicular anterior out-of-plane approach with infraclavicular out-of-plane approach in ultrasound guided subclavian vein cannulation |
During the cannulation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare both the approaches in terms of:
Time taken to get optimal view of structures in ultrasound.
Venous puncture time
Time for successful Cannulation
Number of attempts for successful Cannulation
Number of needle redirections
Ease of insertion
Mechanical complications (Arterial puncture, haematoma, pneumothorax, haemothorax)
Catheter misplacements
|
During the cannulation post operative day 1 |
|
|
Target Sample Size
|
Total Sample Size="110" Sample Size from India="110"
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)
|
01/05/2026 |
| 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="2" Months="0" 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [jayakavya111@gmail.com].
- For how long will this data be available start date provided 21-02-2029 and end date provided 21-02-2034?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Preoperative anaesthetic check-up will be done one
day prior to the planned elective procedure. After the anaesthetic plan is made
to include central venous catheterization, patients satisfying the inclusion
and exclusion criteria will be enrolled in the study after obtaining written informed
consent from the patient. Randomization into either group will be done at this
point using SNOSE technique. Once the patient is shifted inside the operation
theatre, standard monitoring devices including pulse oximeter, non-invasive
blood pressure cuff, ECG leads will be attached and continuous monitoring of
vitals will be done. General anaesthesia and Intubation will be carried out by
the attending anaesthesiologists. With patient lying supine and arm adducted by
side, neck will be extended and head turned to the opposite side at an angle of
30 degrees. A wedge will be placed in between the shoulder blades. Linear
Ultrasound probe of frequency 8-15MHz will be used for this procedure. Under
sterile precautions required for the placement of a central venous catheter,
the procedure will be started. The procedure will be done by a member of the
anaesthesia team with an experience of at least 20 successful cannulations with
both approaches. A screening ultrasound will be done before starting the procedure.
In the supraclavicular anterior out-of-plane approach ultrasound probe will be
held with the left hand and the needle with the right hand. The probe will be
placed on the right side of the neck, at the level of cricoid cartilage so as
to visualize the internal jugular vein (IJV) in short axis. Once IJV is identified,
the probe will be moved caudally down the neck, tracing the course of IJV. Once
the superior border of the clavicle is reached, the probe will be angulated to
visualize the confluence of IJV with subclavian vein as they form the
brachiocephalic vein. The probe will then be adjusted so as to bring the vein
to the centre of ultrasound screen. Pleura will also be visualized in the same
frame. The depth of vein from skin surface will be noted. The needle will be
inserted 0.5 -1 cm lateral to the centre of the footprint of the ultra sound
probe, in between clavicle and probe at an angle of 5 to 10 degrees to the axis
of the probe, directing the needle towards the vein and parallel to the pleura,
under vision. Keeping the depth from skin noted earlier in mind, the skin will
be pierced with a central vein catheter needle. Care will be taken to ensure
that needle will not be inserted more than the measured depth in ultrasound.
Its entry into the vein is visualized in ultrasound view and until there is
flashback or free aspiration of blood in the syringe attached to the needle.
Once free flow of venous blood is confirmed, the ultrasound probe is kept aside
and with the left hand, needle is stabilized at the skin entry point by resting
the hypothenar eminence against the chest to prevent inadvertent insertion into
deeper structures. After successful venous puncture, catheterization will be
done using the seldinger technique. Aspiration of blood from each of the three
lumens will be confirmed before suturing the catheter onto the skin. A sterile
dressing will be applied over the catheter. In the infraclavicular out-of-plane
approach, with similar aseptic precautions, and the patient lying in supine
position and the neck in neutral position, the USG probe will be placed in the
craniocaudal direction with the orientation marker pointing cephalad at the
level of the coracoid process. The Axillary artery and vein will be visualized.
Then the probe will be moved medially tracing both the vessel to visualize the
subclavian vein and artery. On going more medially first the subclavian artery
will become invisible by becoming infraclavicular. Then the probe will be moved
medially to visualize clavicle and major part of subclavian vein. Once the
optimal view is obtained, the distance of the vein from the skin will be noted
to guide needle insertion. The needle will be inserted via the out- of -plane
approach to enter the subclavian vein and at an angle of 45-60 degrees to the
skin and its insertion will be approached step-by-step by moving the probe to
visualize the needle tip. Once successful puncture is noted by visualizing the
needle tip within the vein and by observing back-flow of blood into the syringe
on aspiration, catheterization of the vein will proceed using seldinger
technique. Once free flow of blood is confirmed in all three ports, the
catheter will be sutured to the skin and sterile dressing will be applied. An
observer will note the following parameters- first pass success, number of
attempts, number of redirections, time taken for venous puncture, time taken
for getting an optimal view of structures in ultrasound, time taken for
successful cannulation, and complications like arterial puncture or pneumothorax.
In both groups, the observer will set a timer to note the various timelines
along the procedures. The timer will start with visualization of structures in
ultrasound and then the time of needle insertion will be noted. The time at
which flashback occurs in the syringe will be noted next. Finally, once the
aspiration of blood from each of the three lumens of the catheter is confirmed,
the final time reading will be taken. Position of the catheter tip will be
checked using ultrasound. Presence of catheter tip in the ipsilateral internal
jugular vein or contralateral subclavian vein will be considered as catheter
misplacement. After completion of the procedure, the operator will grade the
ease of the technique using a five-point Likert’s scale. A chest radiograph
will be taken in the postoperative day one to confirm position of the catheter
tip and identify pneumothorax and haemothorax. All data will be documented using a standard
proforma. |