ANZCTR - Registration

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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]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Delivery of Anaesthesia

Condition category

Condition code

Anaesthesiology

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]

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]

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]

Time measured from start of procedure to correct bulbb lit up (measured in seconds)

Secondary outcome [1]

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]

From start to completion of procedure.

Secondary outcome [2]

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]

From start to completion of procedure.

Secondary outcome [3]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Royal Melbourne Hospital - City campus - Parkville

Recruitment postcode(s) [1]

3050 - Royal Melbourne Hospital

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Melbourne Hospital

Address [1]

Royal Melbourne Hospital,
300 Grattan Street
Parkville
Victoria, 3050

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Office for Research, Melbourne Health

Ethics committee address [1]

Level 6 East, Main Building
300 Grattan Street PARKVILLE VIC 3050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/12/2015

Approval date [1]

29/02/2016

Ethics approval number [1]

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]

/AnzctrAttachments/370808-QA2016002 Approval.pdf

Attachments [2]

/AnzctrAttachments/370808-Study CRF_gelatin 211215.pdf

Attachments [3]

/AnzctrAttachments/370808-Study Protocol_gelatin 211215.pdf

Attachments [4]

/AnzctrAttachments/370808-qanrrpicfapr2013_211215.pdf

Contacts

Principal investigator

Name

Dr Patrick Tan

Address

Department of Anaesthesia and Pain Management, The Royal Melbourne Hospital, 300 Grattan Street, Parkville, Victoria 3050, Australia.

Country

Australia

Phone

+61 3 9342 7540

Fax

p.tan28@gmail.com

Contact person for public queries

Name

Irene Ng

Address

Department of Anaesthesia and Pain Management, The Royal Melbourne Hospital, 300 Grattan Street, Parkville, Victoria 3050, Australia.

Country

Australia

Phone

+61 3 9342 7540

Fax

irene.ng@mh.org.au

Contact person for scientific queries

Name

Irene Ng

Address

Department of Anaesthesia and Pain Management, The Royal Melbourne Hospital, 300 Grattan Street, Parkville, Victoria 3050, Australia.

Country

Australia

Phone

+61 3 9342 7540

Fax

irene.ng@mh.org.au

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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Documents added automatically

No additional documents have been identified.

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