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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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000730404
Enrollment
30
Registered
2016-06-02
Start date
2016-05-30
Completion date
2016-06-03
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 in

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.

Sponsors

Dr Irene Ng
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

Anaesthetic residents, registrars and consultants within the department prepared to consent to the trial are eligible for enrollement

Exclusion criteria

Not medical staff employed by the department of anaesthesia. Unwilling to consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026