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Trial registered on ANZCTR


Registration number
ACTRN12617000450314
Ethics application status
Approved
Date submitted
10/06/2016
Date registered
27/03/2017
Date last updated
27/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of a novel real-time needle guidance ultrasound technique with conventional ultrasound for central venous line (internal jugular vein) access among patients in intensive care unit of UNIVERSITY MALAYA MEDICAL CENTRE
Scientific title
Comparison of a novel real-time needle guidance ultrasound technique with conventional ultrasound for central venous line (internal jugular vein) access among patients in intensive care unit of UNIVERSITY MALAYA MEDICAL CENTRE
Secondary ID [1] 289417 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically ill patients 299089 0
Condition category
Condition code
Other 299120 299120 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The procedure is to cannulate internal jugular vein either with the technique of novel real time needle guidance or conventional ultrasound method. Novel real time needle guidance is based on an electromagnetic field that communicates with a transducer and an electromagnetic sensor sheathed by a vascular access needle. Needle movements and related magnetic field variation allow navigation system to compute the location of the transducer and needle. And when the probe and needle which is sheathed with the electromagnetic sensor are placed onto the patient, the target box and trajectory pathway will appear on the screen. Hence with this navigation system, the operator will be able to advance the needle into the target box (cross sectional of vein).
In contrary to this, the conventional ultrasound technique is devoid of the navigation system. The medical officer will complete the procedure, at they will be at least one year of experience in anaesthesia. The procedure will take about 20 to 30 seconds
Intervention code [1] 295006 0
Treatment: Devices
Comparator / control treatment
conventional ultrasound for inserting central venous line into internal jugular vein
Control group
Active

Outcomes
Primary outcome [1] 298590 0
Performance time between conventional ultrasouncd and novel real time needle guidance ultrasound by using a stopwatch.
Timepoint [1] 298590 0
after aspiration of the blood into syringe
Primary outcome [2] 301222 0
to compare cumulative cannulation success by method, allow up to 5 attempts, but if it is unsuccessful, then a senior anesthetist will be required to perform the task..
Timepoint [2] 301222 0
aspiration of blood into syringe
Secondary outcome [1] 324668 0
Any complications that arise from the procedure such as secondary tissue injury, hematoma, bleeding, pneumothorax or hemothorax will be documented

Timepoint [1] 324668 0
24 hours post procedure
Secondary outcome [2] 332064 0
to assess satisfaction of operator towards the methods by using satisfaction 10 point scale, 1 as extremely dissatisfied while 10 as extremely satisfied.
Timepoint [2] 332064 0
after the procedure

Eligibility
Key inclusion criteria
All the patients who require central venous line insertion
Minimum age
12 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Refusal to participate in this study by patient or the legal representative
Patient with history of difficult of getting central venous line at internal jugular vein

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) : http://randomization.com/
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
the sample size was determined by using power study. It was performed using web base sample size calculator (http://www.stat.ubc.ca/~rollin/stats/ssize/n2.html). Considering 90% power and 1% marginal error (type error for alpha value = 0.01 ). This study gives a minimum sample size of 47 per group (based on the median and IQR values obtained from a study reference~Yunseok Jeon, Seungpyo Choi, Heechan Kim. Evaluation of a simplified augmented reality device for ultrasound-guided vascular access in a vascular phantom. Journal of Clinical Anesthesia 2014,485-489) Hence, I will use 50 per group in my study

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7948 0
Malaysia
State/province [1] 7948 0

Funding & Sponsors
Funding source category [1] 293790 0
University
Name [1] 293790 0
University Malaya
Address [1] 293790 0
Jalan Universiti, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Country [1] 293790 0
Malaysia
Primary sponsor type
University
Name
University Malaya
Address
Faculty of Medicine
Jalan Universiti,
University of Malaya
50603 Kuala Lumpur
Malaysia
Country
Malaysia
Secondary sponsor category [1] 292624 0
None
Name [1] 292624 0
none
Address [1] 292624 0
none
Country [1] 292624 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295225 0
UMMC Medical Research Ethics Committee (MREC)
Ethics committee address [1] 295225 0
University Malaya Medical Centre
Lembah Pantai 59100
Kuala Lumpur, Malaysia
Ethics committee country [1] 295225 0
Malaysia
Date submitted for ethics approval [1] 295225 0
15/01/2016
Approval date [1] 295225 0
17/02/2016
Ethics approval number [1] 295225 0
MECID.NO: 20161-2044

Summary
Brief summary
This research will be single centre, prospective, randomized controlled trial involving patient undergoing central venous line insertion in intensive care unit in UMMC from April till August 2016. Participants will be the doctors in anaesthesia with at least a year of clinical experience, and classified as more than a year, more than 2 years, more than 3 years and more than 4 years. Participants are to perform cannulating internal jugular vein access via out of plane method using either NUS or CUS for the patients. Each participant will receive a standardized 5 minute verbal introduction to the GPS technology with navigated ultrasound (NUS), testing of device using phantom blue gel is allowed before participation. Consent is taken either from the patient or the next of kin. Emergency verbal consent is obtained if the next of kin is not immediately available. The participants are randomized to either using NUS or CUS. Procedure time from needle penetration into skin to achieving vascular access was measured in seconds using a stopwatch. The time measurement begins from grasping the USG probe to successful vessel puncture as indicated by blood withdrawn into the syringe. Primary outcome measures are visualization of blood aspirate into syringe, total time to successful puncture of the vessel and the cumulative success. Any complication arise from this procedure will be assessed and documented.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66422 0
Dr Dr. Chew Sou Chen
Address 66422 0
University of Malaya,
Jalan Universiti, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Country 66422 0
Malaysia
Phone 66422 0
+60379672052
Fax 66422 0
Email 66422 0
scchew_3072@yahoo.com
Contact person for public queries
Name 66423 0
Dr Dr. Chew Sou Chen
Address 66423 0
University of Malaya,
Jalan Universiti, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Country 66423 0
Malaysia
Phone 66423 0
+60379492052
Fax 66423 0
Email 66423 0
scchew_3072@yahoo.com
Contact person for scientific queries
Name 66424 0
Dr Mohd Shahnaz Hasan
Address 66424 0
University of Malaya,
Jalan Universiti, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Country 66424 0
Malaysia
Phone 66424 0
+60379492052
Fax 66424 0
Email 66424 0
shahnaz@ummc.edu.my

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary