Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03767010 |
| Other study ID # |
18.275 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 12, 2019 |
| Est. completion date |
February 19, 2021 |
Study information
| Verified date |
May 2022 |
| Source |
Centre hospitalier de l'Université de Montréal (CHUM) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Purpose:
This study is designed to:
1. Implement a website hosting perceptual learning modules (PLMs)
2. Implement and assess a PLM designed to improve the capacity of fourth-year medical
students and first-year residents (novices) to locate the brachial plexus (BP) at the
level of the interscalene groove on surface ultrasound images.
Hypothesis: The hypothesis of the study is that the PLM will improve the ability of novices
to correctly locate the BP at the level of the interscalene groove on surface ultrasound
images, compared to a control group.
Description:
Introduction:
Regional anesthesia has greatly benefited in recent years from the use of ultrasound to
facilitate the location of nerves and of their surrounding structures. Allowing real-time
visualization of anatomical structures, ultrasound has been shown to improve the success rate
of blocks, to decrease procedure times and to improve patient safety by reducing accidental
injections into vessels and nerves.
Ultrasound-guided regional anesthesia training, however, remains a long process. The
conventional way to develop expertise is to practice on patients. The learner does the
techniques under the supervision of an expert, who gives him feedback. While well
established, this approach has several limitations: In addition to being time-consuming, it
is limited by the number of available cases and access to supervising experts.
Perceptual learning modules (PLMs) represent an alternative modality to teach image
interpretation in regional anesthesia and are already used in other fields. PLMs are online
tools created to enhance the development of pattern recognition, a skill required to
efficiently interpret ultrasound-guided images. With PLMs, learners observe a series of
images or videoclips and must answer a question about each image in a short period of time.
Each answer is followed immediately by feedback (the correct answer). By observing a large
number of images online and by receiving systematic and expert feedback, the trainee quickly
learns to extract efficiently the required information from the image.
PLMs developed with real ultrasound images could complement current training methods in
regional anesthesia. A PLM could be especially useful for learning the interscalene block.
Identification of the BP in the interscalene groove is often difficult in the absence of a
reliable vascular marker. Furthermore, the presence of important surrounding structures to be
avoided, like the vertebral artery and the pleura, make accurate image interpretation crucial
to avoid complications.
The aim of this study is to set up a PLM focusing on the location of the BP in the
interscalene groove using ultrasound imaging. As a first step, ultrasound images of the neck
of healthy volunteers will be collected. Subsequently, these images will be uploaded on a
secured website and interpreted by experts. Finally, a study will be undertaken to test
whether the PLM improves the ability of medical students and junior residents (novices) to
correctly locate the brachial plexus in the interscalene groove using ultrasound images.
Methods:
Development of a website to host the new PLM from an already existing model
Two professional programmers collaborating with our team have already developed a website to
host and evaluate another PLM. Using this site as a template, the same programmers will be
responsible for creating a similar website for this project.
Acquisition of images in healthy volunteers
Each volunteer will correspond to a case and each case will consist of three elements:
1. A video of approximately thirty seconds of ultrasound images of the neck;
2. A video taken simultaneously showing the position of the operator's hand and of the
ultrasound probe on the volunteer's neck as the ultrasound images shown in the first
video are being acquired;
3. A static image corresponding to one of the last frames of the first clip.
Validation of cases by experts and construction of a case bank
1. Prior to inclusion in the study, the selected cases will be anonymized and uploaded to
the website and then validated independently by 3 anesthesiologists who are experts in
regional anesthesia;
2. For each case, each expert will have to circle the BP on the static image after viewing
the simultaneous videos without time limitation;
3. For each case, in addition to identifying and locating the BP, the experts will have to
rate the difficulty of identifying and locating the BP on a 4 point Likert scale.
Recruitment of volunteers will continue until a sufficient number of validated cases is
available to build the PLM and two tests.
Development of the PLM (20 cases)
The PLM will be developed with validated cases distinct from those of the performance tests
and will have the following characteristics:
1. For each case, both videos will play simultaneously and loop for up to 90 seconds;
2. A static image including the BP will also be displayed;
3. Participants will need to move a pointer over the static image and place it anywhere
over what they think is the BP;
4. The website will then provide feedback to the participants: the BP will be highlighted
on the static image for up to 30 seconds;
5. After the feedback, the following case will be presented.
Two blocks of 10 cases will be formed. These blocks will contain the same proportion of
"easy" "moderate" and "hard" cases. Cases within a block will be shown in a random order, but
participants will always see the two blocks in the same order.
Development and validation of two tests to assess the performance of learners (10 cases each)
The objective of the tests is different from that of the PLM since their purpose is to assess
the ability of participants to correctly identify the BP at different points during the
study. These tests will have the same format as the PLM, except that no expert feedback will
be provided after each case.
Two test version will be created with different cases. The order of the cases within a test
will be random.
Pilot study of the effect of PLM on learner performance
Fourth-year medical students and first-year residents in anesthesiology will be invited to
participate via email. Consent will be given online. In the first session, participants will
complete a short online questionnaire about their demographics and clinical experience with
ultrasound-guided regional anesthesia. They will also be shown a short tutorial to
familiarize them with the platform, with basic sonoanatomy of the neck, and with the
ultrasound scanning technique.
Subsequently, they will be randomly assigned to one of two groups: Control Group or PLM
Group. Both groups will participate in two on-line sessions. The project will proceed as
follows according to the participant assignment group:
1. Control Group (tests only)
- First 30-minute session, immediately after agreeing to participate in the study
- pre-test (10 cases)
- post-test (10 cases)
- Second session lasting 15 minutes, 6 months after the first session
- 6 months post-test (10 cases)
2. PLM Group (tests and PLM)
- First session of 1h10, immediately after agreeing to participate in the study
- pre-test (10 cases)
- PLM (20 cases with feedback)
- post-test (10 cases)
- Second session lasting 15 minutes, 6 months after the first session
- 6 months post-test (10 cases)
At the end of the study, participants of the Control group will be allowed to complete the
PLM if they wish to.
