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Trial registered on ANZCTR


Registration number
ACTRN12616000730404
Ethics application status
Approved
Date submitted
30/05/2016
Date registered
2/06/2016
Date last updated
22/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing the use of a needle guidance device with free-hand technique in performing out-of-plane ultrasound-guided intervention procedure on a phantom model
Scientific title
Comparing the use of a needle guidance device with free-hand technique in performing out-of-plane ultrasound-guided intervention procedure on a phantom model
Secondary ID [1] 289334 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delivery of Anaesthesia 298944 0
Condition category
Condition code
Anaesthesiology 299019 299019 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Anaesthetists will be recruited to perform a simulated nerve block (performed on a gel phantom). Participants will be randomly allocated to either of the two groups: free-hand group or needle guidance group. The free-hand group (F group) will start the task without the needle guide and the needle guidance group (G group) will start the task with the needle guidance first. A cross-sectional view of the metal rod within the phantom gel will be obtained with the ultrasound. The needle will be inserted in an out-of-plane approach until the target is reached, which will be shown as the correct light bulb turns on. The same task is then repeated with the alternate technique.

The psyllium hydrophilic mucilloid fiber and gelatin phantom will be prepared for this study. Approximately 20 x 12 x 8 cm (length x width x height) specimen will be constructed using a mixture of water, psyllium hydrophilic mucilloid fiber (Brand name: Metamucil) and gelatin. Three 14-gauge metal rods, each connected to an individual electric circuit powered by a standard battery, will be placed 2 cm from the surface parallel to each other. A light bulb is placed within each electric circuit and will light up each time a needle makes contact with the corresponding metal rod. The middle rod is assigned to be the correct target. The other two rods represent the incorrect targets. This arrangement mimics a typical neurovascular bundle found in the human body, where vein, artery and nerve typically lie adjacent to each other.
Intervention code [1] 294894 0
Treatment: Devices
Comparator / control treatment
Study participants will be randomised into performing either the free hand or needle guidance technique first. The control will be the time to perform the procedure without the guide.
Control group
Active

Outcomes
Primary outcome [1] 298481 0
Total procedural time - the time taken from needle insertion to contact with the correct metal rod (ie. when the correct light bulb switches on). An independent observer will be present to collect the data using a stopwatch.
Timepoint [1] 298481 0
Time measured from start of procedure to correct bulbb lit up (measured in seconds)
Secondary outcome [1] 324290 0
Number of needle insertion attempts through the phantom surface. An independent observer will be present to count the number of needle insertion attempts.
Timepoint [1] 324290 0
From start to completion of procedure.
Secondary outcome [2] 324291 0
Number of times an incorrect light bulb switches on, which indicates the number of times the needle is in contact with the incorrect metal rods. An independent observer will be present to observe the number of times an incorrect light bulb is turned on.
Timepoint [2] 324291 0
From start to completion of procedure.
Secondary outcome [3] 324292 0
Proceduralist’s satisfaction score - proceduralists will be asked to rank their satisfaction with both techniques on a scale from 1 (lowest score) to 10 (best score).
Timepoint [3] 324292 0
Assessed immediately at end of procedure

Eligibility
Key inclusion criteria
Anaesthetic residents, registrars and consultants within the department prepared to consent to the trial are eligible for enrollement
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not medical staff employed by the department of anaesthesia. Unwilling to consent

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)
Concealed by opaque envelope. Group only revealed immediately prior to performing procedure.
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) (randomizer.org)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Intervention performed by study participants on gel phantom (not animals or humans)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Values will be expressed as mean and standard deviation. Median and interquartile ranges will be used for data which are not normally distributed. Comparisons between the groups will be performed by t-test for parametric data and Wilcoxon’s signed rank test for non-parametric or not normally distributed data. A P value < 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
30/05/2016
Date of last participant enrolment
Anticipated
3/06/2016
Actual
3/06/2016
Date of last data collection
Anticipated
Actual
3/06/2016
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5866 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 13306 0
3050 - Royal Melbourne Hospital

Funding & Sponsors
Funding source category [1] 293710 0
Hospital
Name [1] 293710 0
Royal Melbourne Hospital
Country [1] 293710 0
Australia
Primary sponsor type
Individual
Name
Dr Irene Ng
Address
Department of Anaesthesia
Royal Melbourne Hospital
300 Grattan Street
Parkville
Vic, 3050
Country
Australia
Secondary sponsor category [1] 292544 0
None
Name [1] 292544 0
Address [1] 292544 0
Country [1] 292544 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295145 0
Office for Research, Melbourne Health
Ethics committee address [1] 295145 0
Level 6 East, Main Building
300 Grattan Street PARKVILLE VIC 3050
Ethics committee country [1] 295145 0
Australia
Date submitted for ethics approval [1] 295145 0
21/12/2015
Approval date [1] 295145 0
29/02/2016
Ethics approval number [1] 295145 0
QA2016002

Summary
Brief summary
The use of ultrasound for vascular access and regional anaesthetic techniques has become an essential tool for day-to-day anaesthesia & critical care. Ultrasound guidance helps avoid complications such as damage to surrounding important structures. It may also increase the success rate of vascular access especially in patient populations with difficult peripheral vascular access (eg. obesity, IV drug use) . Although the ‘out-of-plane’ or short axis approach has been demonstrated to be the easier technique for novice users to learn initially and require less insertion time with potentially higher success rates when compared to the “in-plane” approach, both techniques require a reasonable degree of hand-eye coordination and technical training in this skill is not straightforward.

The development of an ‘in-plane’ needle guide mounted to the ultrasound probe has allowed users to ensure the needle is kept within the narrow ultrasound beam to allow better visualization of the needle. These devices have been demonstrated to significantly reduce attempt number and time for procedure when compared with free hand technique for use in ultrasound-guided central venous access. They have also been shown to reduce procedural time and improve needle visibility in an in-vitro porcine phantom study on novice users. A recent study conducted at our centre demonstrated that use of the needle guide improved needle visualization, time to successful procedure and better user satisfaction scores.

CIVCO has developed a similar purpose ‘out-of-plane’ Accusite needle guidance system that consists of a reusable bracket and customizable depth needle guides (0.5-3.5cm in 0.5cm increments). We propose that this system will have a great application for peripheral and central vascular access (including PICC lines), and also catheter insertion for regional anaesthesia infusion, because these procedures commonly require out-of-plane approach when performed with ultrasound guidance.

Other forms of ultrasound needle guidance systems such as passive electromagnetic and GPS tracking have been investigated showing variable significance in improving ‘out-of-plane’ ultrasound-guided procedure success.

To our knowledge, there are no clinical trials comparing a simple, physical, mountable ‘out-of-plane’ needle guide device with free hand technique. Before we perform a clinical trial, we would like to carry out a pilot study to determine the usefulness of this “out-of-plane” needle guide when used in our department by anaesthetic residents, registrars and consultants with different levels of clinical experience on ultrasound-guided out-of-plane procedure.

Hypothesis: The use of an “out-of-plane” needle guide decreases time to successful attempt compared with a “free-hand” technique on a phantom psyllium hydrophilic mucilloid fiber and gelatin model.
Trial website
Trial related presentations / publications
Nil
Public notes
Attachments [1] 911 911 0 0
/AnzctrAttachments/370808-QA2016002 Approval.pdf
Attachments [2] 912 912 0 0
/AnzctrAttachments/370808-Study CRF_gelatin 211215.pdf
Attachments [3] 913 913 0 0
/AnzctrAttachments/370808-Study Protocol_gelatin 211215.pdf
Attachments [4] 914 914 0 0
/AnzctrAttachments/370808-qanrrpicfapr2013_211215.pdf

Contacts
Principal investigator
Name 66290 0
Dr Patrick Tan
Address 66290 0
Department of Anaesthesia and Pain Management, The Royal Melbourne Hospital, 300 Grattan Street, Parkville, Victoria 3050, Australia.
Country 66290 0
Australia
Phone 66290 0
+61 3 9342 7540
Fax 66290 0
Email 66290 0
[email protected]
Contact person for public queries
Name 66291 0
Irene Ng
Address 66291 0
Department of Anaesthesia and Pain Management, The Royal Melbourne Hospital, 300 Grattan Street, Parkville, Victoria 3050, Australia.
Country 66291 0
Australia
Phone 66291 0
+61 3 9342 7540
Fax 66291 0
Email 66291 0
[email protected]
Contact person for scientific queries
Name 66292 0
Irene Ng
Address 66292 0
Department of Anaesthesia and Pain Management, The Royal Melbourne Hospital, 300 Grattan Street, Parkville, Victoria 3050, Australia.
Country 66292 0
Australia
Phone 66292 0
+61 3 9342 7540
Fax 66292 0
Email 66292 0
[email protected]

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

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