Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000572268
Ethics application status
Approved
Date submitted
26/02/2018
Date registered
16/04/2018
Date last updated
12/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective study on assessing the efficiency of front to back oriented ultrasound probe placed on the side of the neck in adults patients who require internal jugular vein (IJV) catheterization to see the tip of the needle while puncturing the vein in reducing complications.
Scientific title
A prospective study on efficiency of alternative technique “Anteroposterior short axis in-plane ultrasound guided Internal Jugular Vein cannulation” in adults requiring IJV catheterization
Secondary ID [1] 294149 0
None
Universal Trial Number (UTN)
U1111-1209-2202
Trial acronym
APSAX in-plane US Guided IJV cannulation
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Internal Jugular Vein cannulation 306774 0
Critically ill patients 306775 0
Condition category
Condition code
Anaesthesiology 305870 305870 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
: Internal jugular vein (IJV) catheterization is done using standard Seldinger technique. Cannulation, that is puncturing the IJV with needle, is done under ultrasound guidance Conventional practice is to keep ultrasound probe across IJV on the anterior aspect of neck with marker facing medially to obtain short axis view and cannulation is done using out of plane technique where needle tip cannot be seen. In this new technique, short axis view of IJV is obtained by placing the ultrasound probe perpendicularly by the side of the neck anteroposteriorly with the marker facing anteriorly. Ultrasound machine shows cross sectional image of IJV and carotid artery where lateral aspect of neck is on the top of the image and anterior aspect of neck is to the left of the image. Then, the approximate distance between center of the IJV and lateral aspect of neck, that is top of the image, is calculated. This distance is used to mark the skin on the anterior aspect of neck from ultrasound probe. This is the needle entry point. The needle is passed, as in in-plane technique, perpendicular to the ultrasound beam and parallel to the ultrasound probe from the calculated entry point on the anterior aspect of the neck towards the center of the IJV. Needle can be seen moving towards IJV from the left of the image on the screen. The needle can be directed upwards on the screen by directing the needle laterally towards the probe and downwards by directing the needle medially away from the probe for finer adjustments. Once needle punctures the IJV, free aspiration of dark venous blood confirms the needle tip position. As needle entry is perpendicular, to direct the guide wire towards heart, tilt the needle tip towards foot. After threading the guide wire confirm its position using ultrasound before dilatation and catheterization. Entire procedure is done under standard aseptic precaution by doctors with at least one year experience in ultrasound guided IJV cannulation. Chest X-ray is taken after the procedure to confirm the position of the catheter.
Intervention code [1] 300441 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304920 0
Access time in seconds from starting of skin puncture to successful aspiration of venous blood using stop watch.
Timepoint [1] 304920 0
Successful aspiration of venous blood in to syringe
Primary outcome [2] 304921 0
Number of attempts, allow up to 5 attempts, but if unsuccessful, standard ultrasound guided technique is used for cannulation.
Timepoint [2] 304921 0
Successful aspiration of venous blood in to syringe
Primary outcome [3] 304922 0
Success rate assessed using data in the record sheet.
Timepoint [3] 304922 0
Able to advance the guide wire by study technique and found inside the IJV by ultrasound scanning within 5 attempts
Secondary outcome [1] 343622 0
Mechanical complications arising from the procedure like posterior venous wall puncture, carotid arterial puncture, hematoma, bleeding and pneumothorax will be documented
Timepoint [1] 343622 0
24 hours post procedure

Eligibility
Key inclusion criteria
All patients who require IJV catheterization
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Refusal to participate in this study, previous surgery at the site of insertion, infection at the site of insertion, clotting abnormalities, presence of thrombus within the jugular vein and abnormal anatomy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/03/2018
Date of last participant enrolment
Anticipated
Actual
27/08/2018
Date of last data collection
Anticipated
Actual
29/08/2018
Sample size
Target
50
Accrual to date
Final
75
Recruitment outside Australia
Country [1] 9624 0
Brunei Darussalam
State/province [1] 9624 0
Bandar Seri Begawan

Funding & Sponsors
Funding source category [1] 298783 0
Hospital
Name [1] 298783 0
Raja Isteri Pengiran Anak Saleha Hospital
Country [1] 298783 0
Brunei Darussalam
Primary sponsor type
Individual
Name
Ganapathi Aithal
Address
Department of Anaesthesia
Raja Isteri Pengiran Anak Saleha Hospital,
Jalan Putera Al-Muhtadee Billah,
Bandar Seri Begawan BA1712
Country
Brunei Darussalam
Secondary sponsor category [1] 297966 0
None
Name [1] 297966 0
Address [1] 297966 0
Country [1] 297966 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299729 0
MEDICAL AND HEALTH RESEARCH AND ETHICS COMMITTEE
Ethics committee address [1] 299729 0
Executive Screening Suite, Baseline Level One, RIPAS Hospital
Bandar Seri Begawan BA 1710
Ethics committee country [1] 299729 0
Brunei Darussalam
Date submitted for ethics approval [1] 299729 0
10/02/2018
Approval date [1] 299729 0
22/03/2018
Ethics approval number [1] 299729 0
MHREC/MOH/2018/2(1)

Summary
Brief summary
This is a single centre, prospective, uncontrolled research involving patients requiring internal jugular vein catheterization for their optimal management in RIPAS Hospital. All patients requiring IJV catheterization are included in the study. Consent will taken from the patient or next of kin. Doctors with minimum one year experience in ultrasound guided IJV cannulation are given training by detailed explanation and observation of cannulation using new technique twice before allowing to do the IJV catheterization using new anteroposterior short axis in-plane ultrasound guided technique. Access time from starting of skin puncture to successful venous puncture will be measured using stop watch in seconds. Primary outcome measures are aspiration of venous blood in to syringe and number of attempts. Success rate is number of patients in whom able to pass guide wire successfully as confirmed by ultrasound. Any complications due to this technique are recorded.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81394 0
Dr Ganapathi Aithal
Address 81394 0
Department of Anaesthesia
Raja Isteri Pengiran Anak Saleha Hospital,
Jalan Putera Al-Muhtadee Billah,
Bandar Seri Begawan BA1712
Country 81394 0
Brunei Darussalam
Phone 81394 0
+673 2 242424
Fax 81394 0
Email 81394 0
aithalg@yahoo.com
Contact person for public queries
Name 81395 0
Dr Ganapathi Aithal
Address 81395 0
Department of Anaesthesia
Raja Isteri Pengiran Anak Saleha Hospital,
Jalan Putera Al-Muhtadee Billah,
Bandar Seri Begawan BA1712
Country 81395 0
Brunei Darussalam
Phone 81395 0
+673 2 242424
Fax 81395 0
Email 81395 0
aithalg@yahoo.com
Contact person for scientific queries
Name 81396 0
Dr Ganapathi Aithal
Address 81396 0
Department of Anaesthesia
Raja Isteri Pengiran Anak Saleha Hospital,
Jalan Putera Al-Muhtadee Billah,
Bandar Seri Begawan BA1712
Country 81396 0
Brunei Darussalam
Phone 81396 0
+673 2 242424
Fax 81396 0
Email 81396 0
aithalg@yahoo.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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