Clinical trial NCT05968261: Near Remote Method to Guide Performance of Regional Anesthesia
Official title: Implementation and Measurement of a Real-time, Near-remote Method to Operationalize Ultrasound-based Regional Anesthesia/analgesia Procedural Techniques
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anesthesia
Analgesia
Nerve Block
Delivery of Healthcare
Hospitals, Teaching
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will include: (1) mentors, i.e., staff regional anesthesiologists who are experts in ultrasound-guided regional blocks; (2) trainees, i.e., PGY-3 to PGY-5 anesthesia and emergency medicine residents, and emergency medicine staff physicians; and (3) patients, i.e., individuals 18 years and older scheduled for surgery amenable to regional blocks or presenting to the emergency department with traumatic injuries amenable to regional blocks.

Brief 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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

* Mentors: Staff anesthesiologists who are experts in regional blocks.
* Trainees: Senior (PGY3-5) residents (anesthesiology and emergency medicine), and staff (emergency medicine) physicians who have already performed and are comfortable with being supervised near remotely for the regional block at hand.
* Patients: Greater or equal to 18 years of age presenting for surgery or with traumatic injuries amenable to regional blocks.
* All of the above: Able to read and understand English, and competent to provide written informed consent.

Exclusion Criteria:

* Mentors: Staff anesthesiologists who are not experts in the performance/teaching of regional blocks.
* Trainees: Junior (PGY1-2) residents (for any/all types of regional blocks), and senior (PGY3-5) residents and staff physicians who are not comfortable with being supervised near remotely for the regional block at hand.
* Patients: Less than 18 years of age.
* All of the above: Unable to read and understand English, and not competent to provide written informed consent.

Primary outcomes:
measure: Participant opinion
timeFrame: Immediately following block performance
Secondary outcomes:
measure: Block success
timeFrame: Within 30 min following block performance
measure: Block image
timeFrame: Through study completion, an average of 1 year
measure: Complications
timeFrame: Immediately postoperatively
measure: Patient satisfaction
timeFrame: Immediately postoperatively
measure: Number of attempts
timeFrame: Immediately following block performance
measure: Participant feedback
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Hotel Dieu Hospital site (primary) and Kingston General Hospital site (secondary), Kingston Health Sciences Centre
state: Ontario
Study officials:
affiliation: Queen's University. Department of Anesthesiology and Perioperative Medicine
name: Glenio B. Mizubuti, MD, MSc, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: