| CTRI Number |
CTRI/2022/02/039907 [Registered on: 01/02/2022] Trial Registered Prospectively |
| Last Modified On: |
11/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two methods of ultrasound guided neck vein cannulation |
|
Scientific Title of Study
|
Ultrasound-guided internal jugular vein cannulation by Dynamic needle tip positioning
using short axis out of plane approach vs. Long axis in-plane approach for assessing ease and first pass success rate in patients requiring Internal Jugular Vein cannulation : A
prospective randomized study.
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| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mainak Baidya |
| Designation |
Junior Resident (Academic) |
| Affiliation |
AIIMS RAIPUR |
| Address |
OT complex,,A-B Block, 4th Floor,Dept of Anaesthesiology, AIIMS RAIPUR
Raipur
CHHATTISGARH
492099
India |
| Phone |
7907421989 |
| Fax |
|
| Email |
mainak.baidya15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayank Kumar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of Anaesthesiology, AIIMS RAIPUR
Raipur
CHHATTISGARH
492099
India |
| Phone |
9971760416 |
| Fax |
|
| Email |
mayanksonupmch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mayank Kumar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of Anaesthesiology, AIIMS RAIPUR
Raipur
CHHATTISGARH
492099
India |
| Phone |
9971760416 |
| Fax |
|
| Email |
mayanksonupmch@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
AIIMS Raipur |
| Address |
Department of Anaesthesiology,
AIIMS RAIPUR, Chattisgarh |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mainak Baidya |
AIIMS RAIPUR |
OT complex, A-B Block, Department of Anaesthesiology,
AIIMS RAIPUR
Raipur
CHHATTISGARH |
7907421989
mainak.baidya15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS, Raipur |
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: 2||Placement, (2) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional long axis in plane approach technique |
In the LAIP group, after obtaining the view of long axis vein, the probe would be slided to maximize the IJV diameter in the ultrasound image. The needle would be inserted at the point at which the centre line of the probe contacts the skin. The needle should always be adjusted into the ultrasound plane during the procedure and using real time in plane technique, the vein would be cannulated.
Total time duration would be 15 - 30 minutes. |
| Intervention |
Dynamic needle tip positioning using short axis out of plane approach |
For the dynamic needle tip positioning technique, a short axis out - of plane view of the IJV would be obtained and then the needle would be advanced through the skin at a 30° to 40° angle until the hyperechoic needle tip is seen on the ultrasound image. The ultrasound probe would then be moved proximally along the arm and away from the needle insertion point until the needle tip disappears from the ultrasound image. The needle would then be advanced a few millimetres until the needle tip is seen again on the ultrasound image. This stepwise process would be repeated several times until the needle tip is visualized in the lumen of the IJV. At this point, the angle of approach would be decreased, and the same process continued, keeping the needle tip in the centre of the lumen. When the needle appeared to be in the vein and return of venous blood is seen in the syringe, then a guidewire would be placed through the needle into the vein. After identifying the Guidewire in the lumen of the vein using ultrasound, the triple lumen catheter would be inserted.
Total time duration would be 15 - 30 minutes. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients requiring central venous cannulation for hemodynamic monitoring, multiple drug and fluid infusions, ionotropes infusion intraoperatively |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Patients with raised intracranial pressure
3.Obstruction or stenosis of IJV
4.Severe coagulopathy
5. Infection over the insertion site
6. Trauma to the neck |
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
To assess the first pass success rate of Internal Jugular Vein cannulation
by Dynamic needle tip positioning using short axis out plane approach and Long axis in plane
approach. |
Time taken for successful cannulation approximately 15 to 30 minutes after induction. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(1) Cannula insertion failure.
(2) Number of attempts.
(3) Cannulation time in seconds.
(4) Complications (hematoma, chylothorax, pneumothorax, carotid artery puncture) |
(1) Cannula insertion failure (considered to be more than 3 cannulation attempts for a single
arm or the attempted cannulation time more than 5 minutes)
(2) Number of attempts (defined as the number of skin perforations caused by the needle),
(3) Cannulation time in seconds (return of venous blood in the syringe and detection of
guidewire ultrasonographically in the vein).
|
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/02/2022 |
| Date of Study Completion (India) |
25/07/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
Nil |
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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
|
Internal jugular vein (IJV) cannulation is a common invasive procedure in Operation Theatres, ICU, perioperative period and is widely used for hemodynamic monitoring, infusion of drugs and ionotropes. It was performed by palpatory method but Ultrasound (USG) guided cannulation has become more popular in recent years and USG has proven to increase the success rate and decrease the complications. CVC placement in critically ill patients treated in the ICU, an international expert panel recommended in 2012 the utilization of 2D US imaging with a long axis/ in plane technique for vascular access.(2). However there is a controversy regarding which approach is favourable for the USG probe i.e. the Dynamic Needle Tip Positioning (DNTP) using short -axis- out of plane approach or Long-axis- in plane approach. In the Short Axis approach, the relationships of Internal jugular vein to the adjacent vessels are visualised but the needle tip may not be continuously visualised during catheter placement. In the Long Axis Approach, the needle tip including the tip can be continuously visualized, however the relationships to the adjacent vessels may be lost. For dynamic needle tip positioning, the IJV is approached with Short Axis out of plane Technique just until the needle tip is displayed as hyperechoic dot on the monitor between the skin and IJV. While keeping the needle immobile, the probe is parallel shifted away from the operator just until the cross-sectional image of the needle tip disappears. While keeping the probe immobile, the needle is advanced until the cross sectional image on the needle tip reappears on the monitor. The procedure is repeated until the needle tip is inserted profoundly intravascularly. The position of the needle tip in the centre of the vessel can be controlled with needle hub steering. This study will be conducted to compare between the Long Axis and Short Axis techniques (DNTP) in terms of number of skin punctures, number of needle redirections, time required for insertion of guidewire , success of cannulation and any complications. . |