42 Participants NeededMy employer runs this trial

Communication Delays for Regional Anesthesia

(ICARUS Trial)

JG
SA
Overseen BySharon Amey
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Nova Scotia Health Authority
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Hypotheses The investigators hypothesize that a communication delay of 80 seconds compared to no delay will be associated with longer procedural times and decreased quality during brachial plexus block scanning. Secondly, the communication delay will be associated with more errors in treatment and a delay of essential treatments in a medical emergency.

Background The near future will see crewed missions in deep space. As the number of people travelling to space increases, so will the chances of traumatic injury and other medical emergencies. Given many changes to body systems in microgravity and the scarcity of equipment and personnel in space, treating medical emergencies is already very difficult. Because most pain medications interfere with cognition, and general anesthesia would be very risky in these conditions, regional anesthesia ('nerve blocks') has been suggested as a less risky alternative. However, nerve blocks are highly specialized skills and responding to medical emergencies in general requires extensive medical training, it is likely that astronauts will require guidance from earth-based physicians.

As crews venture deeper into space, the ability of teams to communicate in real time with earth-based medical teams decreases. For missions to the moon, communication delays of 3 to 160 seconds in each direction are expected. In the event of a medical emergency, space crews may require consultation with ground teams. The investigators predict that this communication delay will impact task duration, create opportunities for miscommunication and potentially result in higher rates of complications.

Objectives

* Quantify the difference (communication delay versus no delay) in time to identify critical structures while scanning brachial plexus block sonoanatomy and time to essential treatment during a medical emergency.

* Quantify the difference (communication delay versus no delay) in quality and ease of imaging while scanning brachial plexus block sonoanatomy.

* Quantify the difference in completeness of emergency treatment using a composite measure (communication delay versus no delay).

* Describe the challenges and solutions for team functioning and remote mentorship when a communication delay exists.

Methods This is a within-subjects, mixed-methods, simulation-based randomized study. Regional anesthesia novices (medical students) and Canadian Armed Forces (CAF) medical technicians or CAF nurses will be recruited and given a 4-hour training session on the basics of brachial plexus blocks and their complications. Participants will be placed in teams of 3, participating in two simulation scenarios. Once the team enters the simulation space, they will be able to ask for assistance from a "remote" team of experts. Teams will be guided through identifying the sonoanatomy for brachial plexus blocks and responding to a complication from placing a peripheral nerve block. Every team will complete both the no communication delay and 80-second communication delay. Teams will be randomly assigned the order in which they perform each condition.

Time to "block" (when the participant identifies where they would place the local anesthetic) and time to essential treatments during an emergency will be recorded. Participants will rate the ease of ultrasound image acquisition and ease of communication, while the expert team will rate the quality of the ultrasound images and the ease of communication. Quantitative outcomes will be analyzed using univariate statistics. After the scenario, teams will debrief the scenario with a focus on communication, safe identification of target nerves and their ability to respond to a complication. Transcriptions of the debriefing sessions will be analyzed for themes using qualitative analysis.

Are You a Good Fit for This Trial?

This trial is for medical students, Canadian Armed Forces medical technicians, or nurses with little experience in regional anesthesia. Participants must be able to attend a training session and take part in team-based simulation exercises.

Inclusion Criteria

Canadian Armed Forces (CAF) medical technicians or nurses at a minimum of Rank Qualification Medical Technician Private
Medical students from Dalhousie University

Exclusion Criteria

Prior experience and training in regional anesthesia techniques
Visual or auditory impairments that make unmodified video chats difficult

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants receive a 4-hour training session on ultrasound theory, needling skills, and complications of nerve blocks

4 hours
1 session (in-person)

Simulation

Participants engage in two simulation scenarios with and without communication delay, focusing on nerve block procedures and emergency response

Half-day session
1 session (in-person)

Debriefing

Participants debrief the scenarios focusing on communication, safe identification of target nerves, and response to complications

Immediately after simulation

Follow-up

Participants are monitored for effectiveness of training and simulation outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares how an 80-second communication delay versus real-time communication affects the ability of teams to perform ultrasound-guided nerve blocks and respond to simulated medical emergencies. Each team experiences both scenarios in random order.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Delayed communicationExperimental Treatment1 Intervention
Group II: Real-time communicationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials
302
Recruited
95,300+