| CTRI Number |
CTRI/2023/02/049441 [Registered on: 03/02/2023] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of three methods of inserting cannula in major neck vessel using ultrasonography |
|
Scientific Title of Study
|
COMPARISON OF THREE APPROACHES FOR ULTRASOUND GUIDED INTERNAL JUGULAR VEIN CANNULATION: A PROSPECTIVE RANDOMIZED STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRERANA NIRAV SHAH |
| Designation |
PROFESSOR |
| Affiliation |
GSMC KEMH |
| Address |
Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869117027 |
| Fax |
|
| Email |
PPS@KEM.EDU |
|
Details of Contact Person
Scientific Query
|
| Name |
Neethu M Punnen |
| Designation |
Resident |
| Affiliation |
GSMC KEMH |
| Address |
Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
8762252089 |
| Fax |
|
| Email |
neethupunnen96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neethu M Punnen |
| Designation |
Resident |
| Affiliation |
GSMC KEMH |
| Address |
Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
8762252089 |
| Fax |
|
| Email |
neethupunnen96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology 1st Floor Old Building GSMC KEMH
Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA
400012 India Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA
400012
India |
|
|
Primary Sponsor
|
| Name |
GSMC KEMH |
| Address |
Department of Anaesthesiology 1st Floor Old Building GSMC KEMH
Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA
400012 India Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA
400012
India |
| 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 |
| Neethu M Punnen |
GSMC KEMH |
Department of Anaesthesiology 1st Floor Old Building
Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA
400012 India Mumbai MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA |
8762252089
neethupunnen96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comiittee- IEC2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
LAX |
LAX approach for ultrasound guided internal jugular vein cannulation. Duration taken for the procedure 10-20 minutes |
| Comparator Agent |
M-OAX |
M-OAX approach for ultrasound guided internal jugular vein cannulation. Duration taken for the procedure 10-20 minutes |
| Intervention |
SAX |
SAX approach for ultrasound guided internal jugular vein cannulation. Duration taken for the procedure 10-20 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of either gender
Scheduled for surgery under general anaesthesia needing IJV cannulation as a part of standard care
|
|
| ExclusionCriteria |
| Details |
Patient not willing for study
Any infection at the site of IJV
IJV Cannula insitu
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the three approaches (SAX, LAX, and M-OAX) for ultrasound guided successful internal jugular cannulation on successful first needle pass |
pre insertion, during insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of needle passes:
Duration of cannulation: Time starting from insertion of introducer needle to the end of IJV cannula placement (not including the suture and fixation time).
Incidence of complications namely carotid artery puncture, posterior venous wall puncture, local haematoma formation, puncture site bleeding, catheter misplacement, haemothorax, pneumothorax, arrhythmias, thrombosis and embolism. |
during insertion, post insertion |
|
|
Target Sample Size
|
Total Sample Size="117"
Sample Size from India="117"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/02/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Internal jugular vein (IJV)
cannulation is the most often used central venous cannulation technique. The
use of ultrasonography for IJV access offers prompt, secure, and reliable
guidance for needle placement. In comparison to the landmark technique, it also
leads to a higher percentage of cannulation that are successful on the first
try, a shorter average cannulation time, and a decrease in mechanical problems.
Several approaches can be used for ultrasound guided IJV cannulation, including
the short axis view (SAX), long axis view (LAX), combination of short and long
axes views (SAX initially, then rotation to LAX to see needle entry into the
vein) namely oblique axis view (OAX) and medial oblique axis view (M-OAX). Each
method has advantages and drawbacks of its own.
The primary objective of the study is to assess
and compare the three approaches for ultrasound guided successful internal
jugular cannulation on successful first needle pass and the secondary objective
is to compare number of needle passes, duration of cannulation [Time from
starting of insertion of introducer needle to the end of IJV cannula placement(not
including the suture and fixation time)], and incidence of complications namely
carotid artery puncture, posterior venous wall puncture, local haematoma formation, puncture site bleeding, catheter misplacement,
haemothorax, pneumothorax, arrhythmias, thrombosis and embolism |