Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT01965314 |
| Other study ID # |
Haystack USgABPB sim-training |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
October 11, 2013 |
| Last updated |
February 1, 2016 |
| Start date |
July 2010 |
| Est. completion date |
November 2010 |
Study information
| Verified date |
February 2016 |
| Source |
Cork University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Ireland: Department of Health and Children |
| Study type |
Interventional
|
Clinical Trial Summary
Investigators hypothesize that virtual reality based training offers an additional learning
benefit over standard training (using cadaveric dissection and human volunteers) in
preparing novice anaesthetists to perform their first Ultrasound guided Axillary Brachial
Plexus Blockade (USgABPB) in the clinical setting.
Investigators hope that this body of work will aid the development of a visuo-haptic
simulator used to improved training of doctors in performing USgABPB. Ultimately any patient
having this procedure carried out in the future should benefit. In particular it will avoid
the need for novice trainees to practice new techniques on patients.
Description:
Ultrasound guided axillary brachial plexus blockade (USgABPB) is a commonly performed
medical procedure which enables the performance of surgery on the upper limb without general
anaesthesia. Its competent performance entails complex, simultaneous interactions between
three processes. These are active management of the patient, acquisition and interpretation
of ultrasound images, and the placement a needle tip close to specific nerves to facilitate
deposition of local anaesthetic. Currently, the procedure is taught using two-dimensional
drawings, cadaveric specimens, videos, 3D animations, live demonstrations, and/or supervised
clinical practice. Simulated practice, using tofu-based or animal models, have been used to
bridge the gap from knowledge to clinical performance. Training in medical procedural skills
is currently undergoing important change. Factors including altered patient expectations and
the European Working Time Directive (2000/34/EC amending Directive 93/104/EC) limit the
number of clinical learning opportunities available to trainees. These changes are likely to
decrease particularly the number of opportunities for trainees to learn and practice
procedural skills in a clinical setting. The traditional Halstedian apprenticeship model of
medical training is being challenged. In this model, training is associated with
progressively less supervision as part of progressive independence. "See one, do one" is no
longer an appropriate method for teaching procedural skills because patients are necessarily
exposed to inexperienced practitioners. This model requires a large investment of time by
both trainer and trainee in the clinical environment. Its application decreases the
efficiency of operating room activity. These circumstances pose medical trainers and
training bodies with a dilemma, a decrease in the number of individual opportunities implies
that the total duration of training should increase or a lesser level of competence accepted
at completion of training
Simulation has been used widely for training in and assessment of medical procedural skills.
Applied to essential anaesthetic skills, simulation may be more efficient than the
apprenticeship approach. This may offer a partial solution to the problem of limited
clinical learning opportunities for USgPNB. Simulated practice with formative feedback has
been shown to be of benefit in the rapid acquisition of basic ultrasound skills by
inexperienced clinicians. Ultimately, the purpose of simulated practice of medical
procedures is to enhance clinical performance. One proven important role for simulation is
to prepare novice clinicians to bridge the gap between acquiring knowledge and initial
clinical performance. Significantly, the Food and Drug Administration (FDA) has recently
mandated that clinicians who perform carotid stenting using a particular stent should train
to a defined level of proficiency on a simulator before they perform the procedure on a
patient.
With institutional ethical approval and having obtained written informed consent from
participants (patients and anaesthetists) 20 College of Anaesthetists (RCSI) affiliated
trainees who have no experience of performing ultrasound guided regional anaesthesia will be
recruited. Participating anaesthetists will provide baseline personal data including
previous experience with peripheral nerve blockade and simulators, using a web-based
collection facility (www.surveymonkey.com or similar). They will perform baseline
psychomotor tests prior to beginning training. Baseline visuo-spatial ability will be
assessed using the card rotation, cube comparison, and map planning tests (Educational
Testing Service) or similar. Psychomotor ability will be assessed using a grooved pegboard
(Lafayette Instruments, Lafayette, IN) or similar. All participating anaesthetists will
receive standardized two hour didactic training encompassing relevant anatomy, ultrasound
(physics, function and interpretation), pharmacology of relevant agents, indications/
contraindications of the block and complications of the procedure. Participants will be
taught to perform USgABPB using a technique as described in Appendix IV and V of 'The
American Society of Regional Anesthesia and Pain Medicine and the European Society of
Regional Anaesthesia and Pain Therapy Joint Committee Recommendations for Education and
Training in Ultrasound-Guided Regional Anesthesia'. This technique uses a transverse (or
short-axis) view, on ultrasound imaging, of the axillary brachial plexus and axillary blood
vessels. The needle is inserted in a sterile fashion using an 'in-plane' approach, that is,
the needle shaft and tip will remain visible on ultrasound view throughout it course towards
the relevant nerves. Following this initial period of common training subjects will be
randomly allocated (using computer generated random numbers) to one of two groups of equal
size for additional training which will occur in parallel over a two hour period, namely a
simulator trained group (SG) or a control group (CG). Following the educational intervention
all subjects will be asked to give written feedback on the content and delivery of the
session.
Traditional training TG subjects will be offered multimodal training. This will be comprised
of demonstration by suitably trained individuals of relevant anatomy using pre-existing
cadaveric samples, performing ultrasound scans of the relevant areas on volunteers under
expert supervision, and the practice of needle insertion under ultrasound-guidance using
commonly used tissue phantoms (turkey breasts). All ultrasound examinations performed on
volunteers or during the clinical performance on patients will use a Sonosite M Turbo (or
similar device) with a 7-12 MHz 38mm linear probe. This training session will last two
hours.
Simulator training In addition to traditional training the SG group will participate in a
period of simulator based training. Following initial familiarization with the simulator SG
participants will identify relevant structures and follow their course in the virtual arm.
They will insert a virtual needle into the virtual environment and advance it using an
in-plane technique towards various target structures. They will be given immediate directed
feedback by an expert and offered the opportunity for repetitive, deliberate practice. The
simulator, which SG participants will use, will comprise of a PHANTOM Desktop
(http://www.sensable.com/), an haptic immersive workbench and the H3D API
(http://www.sensegraphics.se/). The SG subject will scan and perform procedure specific
tasks on a virtual arm. The model of the arm will be informed using MRI or ultrasound
supervolume DICOM datasets. This training session will last two hours.
Assessment Within two weeks of the educational intervention all participants' first clinical
performance of an ultrasound guided nerve block, specifically an ultrasound guided axillary
brachial plexus blockade, will be video recorded for subsequent analysis by two experts in
UGRA. Patients involved will require anaesthesia for forearm/wrist/hand surgery where
USgABPB would ordinarily be offered as standard care. Subsequent care of the patient may
include general anaesthesia, as clinically indicated. Intravenous sedation will be offered
and administered as clinically indicated (Midazolam up to a maximum of 0.05mg/kg).
Subjects will perform the procedure, using an in-plane approach and short-axis view (see
above), in the presence of a supervising trainer, blinded to training group, who is
available to intervene if required, for patient safety, or requested by the subjects
themselves. Patients involved will also be blinded to subject allocation. Using a video
recording device Sony Handycam HDR-XR520VE, or similar, the performance of a clinician
indicated USgABPB for a scheduled operation on patients will be recorded. The video-taping
will target primarily the anaesthetist performing the clinically indicated ultrasound guided
regional anaesthetic technique in the usual fashion at Cork University Hospital. The
recording will proceed in a manner aimed to conceal the identity of the patient and maintain
confidentiality. All efforts will be taken to ensure the recording will not include images
of the patients face. For the purpose of blinding, a similar effort will be made conceal the
identity of the anaesthetists performing the block by avoiding shots of their faces. The
recording will include a pan shot of the setup of the room the block will take place in.
This will indicate the location of the patient, the ultrasound machine, the trolley with the
sterile equipment required, the assistant, the monitor, the emergency drugs, and the
anaesthetist performing the block. Before commencing the block the camera will be fixed in
position focusing on the axilla, with needle insertion site, ultrasound probe and the
movements of the anaesthetist's hands recorded. The acquired ultrasound image will be
recorded concurrently. After expert assessment of trainee performance and completion of the
dataset all recorded video will be destroyed.
For the purpose of the study the subjects will be give some specific directions.
1. Position the patient and equipment appropriately.
2. They will be asked to perform a pre-procedure ultrasonic survey of the relevant area,
specifically identifying the four relevant nerves (musculocutaneous, radial, median,
and ulnar).
3. Perform a sterile four nerve ultrasound-guided axillary brachial plexus block,
utilizing a single skin entry point (where possible), short axis view of the brachial
plexus, and needle in-plane approach.
4. They will be asked to demonstrate the effectiveness of the blockade.
Following the recorded performance of the procedure the subjects will be asked to complete a
written questionnaire indicating their confidence in performing the procedure and their
perception of the influence of external stressors (including the presence of a camera).
