Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05968261 |
| Other study ID # |
6038020 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2025 |
| Est. completion date |
July 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Queen's University |
| Contact |
Stephanie Chevrier, MD |
| Phone |
6138090424 |
| Email |
stephanie.chevrier[@]kingstonhsc.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Ultrasound-guided regional anesthesia/analgesia techniques (or simply, 'regional blocks')
have gained popularity as they can reduce, and sometimes even eliminate, the need for opiate
analgesics (and, consequently, their side effects), thereby improving patient safety,
reducing length of hospital stay and medical costs, and improving patient satisfaction.
However, a major barrier to mainstream uptake of such techniques relates to training. These
techniques require the acquisition of new skills under expert guidance, which is often not
possible given the daily demands placed upon anesthesiologists. As a result, many
opportunities for providing regional blocks may be missed.
The purpose of this study is to implement a new real-time 'near remote' guidance method in
which trainees who are to perform regional blocks can do so via tele-mentoring under expert
guidance. This will be done using a novel technology whereby the ultrasound image is
concurrently displayed on an iPad screen (for the block operator/trainee) as well as on the
(near remotely supervising) expert mentor's smartphone. Trainees and mentors will use this
method to perform various standard of care regional blocks, either in the perioperative or
emergency department settings. Participants' opinions of the novel teaching and learning
method will be assessed.
Description:
Ultrasound-guided regional anesthesia/analgesia techniques (herein referred to simply as
'regional blocks') have gained popularity as they can reduce, and sometimes even eliminate,
the need for opiate analgesics (and, consequently, their side effects), thereby improving
patient safety, reducing length of hospital stay and medical costs, and improving patient
satisfaction. However, a major barrier to mainstream uptake of such techniques relates to
training. These techniques require the acquisition of new skills under expert guidance, which
is often not possible given the daily time-sensitive and competing demands placed upon
anesthesiologists. Furthermore, staff shortages and increasing demands caused by the COVID-19
pandemic have limited expert availability for one-on-one guidance even more. As a result,
many opportunities for providing regional analgesia may be missed or performed in the absence
of expert guidance.
Currently, expert staff regional anesthesiologists would ideally be available to supervise
regional blocks. In clinical practice, however, if no staff regional anesthesiologist is
available to supervise, senior anesthesia residents (post-graduate years 3 to 5) will often
proceed with performing lower-risk blocks (e.g., adductor canal blocks) independently
provided they feel confident and comfortable with the technique. If, however, the senior
anesthesia resident is not comfortable with performing a higher-risk block without
supervision, the patient would likely then receive general anesthesia combined with a
multimodal analgesic regimen for perioperative pain control.
The purpose of the current study is to implement a new real-time 'near-remote' guidance
method, in which trainees who are to perform regional blocks can do so via tele-mentoring
under expert guidance. This will be done using an ultrasound-linked iPad which is a novel
technology whereby the high-resolution ultrasound image is concurrently displayed on an iPad
screen (for the block operator/trainee) as well as on the (near remotely supervising) expert
mentor's smartphone. The expert mentor will either be at a distance in the same room or in an
adjacent room, but readily available to intervene quickly if necessary. Trainees and mentors
will use this method to perform various standard of care regional blocks on patients, either
prior to elective surgical procedures or in the emergency department in the context of trauma
injuries. All regional blocks will be as per standard of care, except they will be performed
under expert 'near-remote' guidance.
Following the regional block performed via tele-mentored expert-guidance, both the trainee
and mentor will complete a questionnaire pertaining to that particular block. Questionnaires
will be completed electronically via Qualtrics. Block success will also be assessed (i.e.,
sensory block to ice within 30 min following block performance, as per standard of care) and
documented. Towards the end of the study, voluntary focus group sessions will be held, during
which trainees and mentors will have the opportunity to provide feedback regarding the newly
implemented teaching and learning method. Thematic analyses will then be conducted.
Success with the current study may lay the groundwork for future research investigations to
examine the feasibility of guiding such blocks by more remote methods (i.e., with the expert
more than a few feet away).
