| CTRI Number |
CTRI/2023/05/052402 [Registered on: 09/05/2023] Trial Registered Prospectively |
| Last Modified On: |
03/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
ULTRASOUND GUIDED AXILLARY VEIN CANNULATION |
|
Scientific Title of Study
|
ULTRASOUND GUIDED OUT-OF-PLANE VERSUS IN-PLANE TRANSPECTORAL APPROACH FOR RIGHT AXILLARY VEIN CANNULATION – PROSPECTIVE RANDOMISED INTERVENTIONAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sowmya M |
| Designation |
Post graduate |
| Affiliation |
karnataka institute of medical sciences |
| Address |
Department of Anesthesiology karnataka Institute of Medical Sciences, Vidyanagar Hubli- Dharwad
Dharwad
KARNATAKA
580032
India |
| Phone |
9483929628 |
| Fax |
|
| Email |
sowmya96m@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jagadish B Alur |
| Designation |
Assosciate Professor |
| Affiliation |
Karnataka institute of medical sciences |
| Address |
Department of Anesthesiology karnataka Institute of Medical Sciences, Vidyanagar Hubli- Dharwad
Dharwad
KARNATAKA
580032
India |
| Phone |
9449455665 |
| Fax |
|
| Email |
alurjaggs9495@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jagadish B Alur |
| Designation |
Assosciate Professor |
| Affiliation |
Karnataka institute of medical sciences |
| Address |
Department of Anesthesiology karnataka Institute of Medical Sciences, Vidyanagar Hubli- Dharwad
Dharwad
KARNATAKA
580032
India |
| Phone |
9449455665 |
| Fax |
|
| Email |
alurjaggs9495@gmail.com |
|
|
Source of Monetary or Material Support
|
| karnataka institute of medical sciences , Hubli |
|
|
Primary Sponsor
|
| Name |
Dr Sowmya M |
| Address |
Post graduate Department of Anaesthesiology,Karnataka Institute of Medical Sciences,Vidyanagar, Hubli |
| Type of Sponsor |
Other [self] |
|
|
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 Sowmya M |
Karnataka Institute of Medical Sciences |
Department of Anesthesiology Room no.206, karnataka Institute of medical sciences,
Vidyanagar Hubli- Dharwad
Dharwad
KARNATAKA |
9483929628
sowmya96m@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee , KIMS, Hubli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 2||Placement, (2) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Axillary vein central venous cannulation |
ULTRASOUND GUIDED OUT-OF- PLANE VERSUS IN-PLANE TRANSPECTORAL APPROACH FOR RIGHT AXILLARY VEIN CANNULATION – PROSPECTIVE RANDOMISED INTERVENTIONAL STUDY |
| Comparator Agent |
ultrasound guided right axillary vein central vein cannulation- in-plane versus out-of-plane |
ULTRASOUND GUIDED OUT-OF- PLANE VERSUS IN-PLANE TRANSPECTORAL APPROACH FOR RIGHT AXILLARY VEIN CANNULATION – PROSPECTIVE RANDOMISED INTERVENTIONAL STUDY |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anaesthesiologists (ASA) physical status 1 and 2
Patients undergoing any surgical procedures requiring CVC in Operation theatres
Patients in Intensive Care Units requiring CVC |
|
| ExclusionCriteria |
| Details |
Pregnant women, Patients on anticoagulants, deranged coagulations parameters, BMI>30kg/m2,Patients on Non-invasive ventilation/CPAP, Patient refusal, More than 5 venous/punctures, Chronic kidney disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the frequency of first attempt successful axillary vein cannulation by the Seldinger technique using out- of-plane(short-axis) ultrasound guidance versus in-plane(long-axis) imaging. |
1-2 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compared the number of attempts that are necessary for the cannulation of the right axillary vein along with the number of needle redirections that has to be done for final cannulation of the vein. Incidence of complications and the number of times the procedure was abandoned while comparing between the two image planes |
1-2 hours |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/06/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Central
venous cannulation is performed routinely in critically ill patients and those undergoing major surgical procedures for hemodynamic monitoring, infusion of vaso-active substances and for rapid fluid resuscitation or rapid blood replacement therapy.Ultrasound
(US) guidance is now considered the gold standard technique for central venous catheter insertion via
internal jugular vein (IJV). The subclavian vein
(SCV) is a useful alternative to the IJV and the landmark technique have been in practice for many years, despite
the potential procedural complications. It
is not easily amenable to US-guided access, because the clavicle obstructs the view of the vessels . In
contrast the axillary vein that extends from the lateral border of the first rib to the outer border of the teres major
is visible with ultrasound and is becoming
the popular route for central
venous access. The axillary vein is an easily accessible vessel that
can be used for ultrasound- guided central vascular access and offers an
alternative site to the internal jugular
and subclavian vein and ultrasound guidance has been shown to improve the chances of successful axillary
vein cannulation while minimizing
the complications. |