- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07675863
Impact of Communication Delays on Anesthesia Response to Medical Emergencies and Ultrasound-Guided Regional Anesthesia (ICARUS)
The Impact of Communication Delays on Anesthesia Response to Medical Emergencies and Ultrasound-Guided Regional Anesthesia: A Randomized Simulation Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background and Rationale The number of people travelling to space is increasing rapidly with increased government funded exploration, private space industry development, and even space tourism. Although historically the risk of traumatic injuries and medical emergencies has been low, with the frequency, complexity and duration of missions increasing, emergencies can be expected. Treating traumatic injuries and medical emergencies in space comes with a high level of difficulty given physiologic changes associated with microgravity (fluid shift, dehydration, altered autonomic responses, airway edema, etc) and travel outside of earth magnetosphere exposing astronauts to higher ambient radiation levels (inducing immune suppression). Most analgesic medications have some degree of cognitive impact (drowsiness, mental fogging, or confusion) which could compromise astronauts ability to participate in critical activities. Deep sedation or general anesthesia would be very risky given the physiologic changes and the difficulty of advance airway maneuvers in microgravity. For these reasons, regional anesthesia has been suggested as a solution for pain control with minimal hemodynamic and cognitive side effects. Previous commentators have suggested that regional anesthesia is a solution to pain management and to allow surgical procedures in microgravity. However, since 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 medical professionals.
Planning for medical emergencies will be an essential part of preparation and training. In the more than 50 years of space exploration, NASA has selected 360 astronaut candidates, 33 of them have been physicians. On most missions the crew includes a "Chief Medical Officer" (CMO), an astronaut chosen to provide in-flight medical care. The CMO's receive 40 hours of pre-mission basic medical training on the use of essential on-orbit medical equipment and the recognition of a variety of medical conditions. On missions to the ISS the CMO's can consult earth-based flight surgeons and injured persons can be evacuated to a treatment facility on earth, however with further exploration communication becomes delayed and evacuation impossible.
An approximate three-second minimum communication delay currently exists between Earth and Moon, but larger data transfers using information dense communication (like video consultation) a delay of up to 163 seconds is predicted. With such a long delay, the ability for real time communication is lost. The acting CMO will likely need to communicate with terrestrial-based flight surgeons and any extended delay in emergency medical treatment would be expected to increase negative outcomes on patient care. The purpose of this study is to assess the degree of impact of a communication delay on remote mentorship of a procedure (nerve block). Secondly, to assess the impact on accuracy of and timing of response to a medical emergency.
Statement of Research Questions
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.
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
Study Design This is a within-subjects, mixed-methods, simulation-based randomized study. Participants will be placed in medical teams of 3 participants. 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. All teams will perform the same scenarios and emergencies. Teams will communicate via real-time video chat or video recording (delay) with anesthesiologists experienced in regional anesthesia.
Recruitment and Allocation The investigators will recruit medical students from Dalhousie University and Canadian Armed Forces (CAF) medical technicians at a minimum of Rank Qualification Medical Technician Private or CAF nurses for this study. The investigators intend to recruit 42 students, medics or nurses placed in 14 teams of 3 participants.
Recruitment will be done via email advertisements and physical posters for medical students. For military personnel, the opportunity will be disseminated via email through the unit training cell to avoid real or perceived coercion from the chain of command.
Training session Recruited participants will be given a 4-hour training session on the basics of ultrasound theory, knobology, needling skills, local anesthetics, sono-anatomy, and complications of nerve blocks. This session will be developed and led by fellowship trained regional anesthesiologists. There will be opportunities to practice image acquisition on live models with feedback. This session will take place within 4 weeks of the study.
Simulation scenarios Each team will run two scenarios during the same half day session. Every team will complete both the no communication delay and communication delay (80 seconds) conditions. The order of conditions (delay vs no delay), order of emergency scenario, and the type of block requested will be randomized. One scenario will be completed followed by a debriefing session. Then the team will complete a second scenario with a different nerve block and emergency, followed again by a debriefing session. The scenarios and nerve blocks will be different so the condition (delay vs no delay) will also be randomized.
Each team will have 3 participants (one lead participant with supporting team members) (referred to here as the "treating team"). Teams will be prompted that safe decision making and action is crucial in these scenarios. Once the team enters the simulation space, they will be able to ask for assistance from a "remote" team of experts. In a nearby room, a group of regional anesthesiologists (co-investigators) will guide the participants through the scenario (referred to here as "mission control"). The lead participant will be asked to scan a live model to identify the critical anatomical structures needed to perform a brachial plexus block (axillary or supraclavicular approach).
The scenario will then shift to a response to a medical emergency related to the block (local anesthetic systemic toxicity (LAST) or anaphylaxis). The scenario will prompt quick action for a potentially life-threatening situation. As with the ultrasound scanning for the block, teams can ask for help from the remote team of experts in 'mission control' as many times as they deem necessary.
Debriefing Following the scenario, the treating team and the mission control team will meet in the same room to debrief the scenario. An investigator who is trained in debriefing simulation scenarios will lead the debriefing session. The discussion will focus on the following objectives: 1. Safe conduct of a nerve block, including identification of sonoanatomy, 2. Timely response to the medical emergency, and 3. Clear communication among team members to provide safe care.
Statistical analysis and power calculation Quantitative Demographics will be collected (age, gender, prior medical training, experience with nerve blocks) and reported in aggregate for the purposes of external validity and generalizability. Outcomes will be compared between no communication delay versus communication delay (within subjects, paired data). Univariate comparisons will be analyzed for ordinal outcomes (ease of image acquisition, quality of images, ease of needle placement, composite score), and continuous data (time to identification of anatomy, time to definitive treatment).
Qualitative Two investigators will separately review the transcripts for themes using inductive coding as they become available. The codes will be analyzed, and eventually grouped into categories that highlight the underlying themes. The investigators will meet to discuss and come to consensus regarding emerging themes and larger categories after every 5 transcripts analyzed. Illustrative quotes will be used when reporting the themes.
Sample Size The sample size is based on time for scanning and time to respond to a medical emergency. While performance time is only one marker of ease and success for regional anesthesia, because this study only includes scanning and identification of sonoanatomy (does not involve needle passing and injection in a model), time was felt to be an important outcome for sample size calculation. The average time is 5-6 minutes (standard deviation 1.8-2.0) to perform a brachial plexus block. A paper examined the difference in performance time from early to late learning curve, finding that early in the learning curve performance times between 1.5 to 3 times that of the average performance time. Assuming an average time of 6 minutes (standard deviation 2.0) compared to 9 minutes (1.5x the baseline), an alpha of 0.05, power of 80%, and matched pairs t-test, a sample size of 6 teams would be needed (G*Power, Dusseldorf, Germany).
The investigators were unable to locate a study directly addressing treatment delays for LAST, or anaphylaxis. In a study of out-of-hospital cardiac arrest, the median time to bystander CPR was 2 minutes. Patient who received CPR 4-5 minutes following arrest had much worse survival (odds ratio 0.73) compared to those that received CPR within 1 minute of arrest. The investigators converted the study median 2.0 (IQR 1.0 - 5.0) to mean 2.67 (SD 2.97) using Wan and colleagues method. Assuming an alpha of 0.05, power of 80%, and matched pairs t-test, a total sample size of 11 teams is needed to detect a difference of 3 minutes in time to definitive treatment (G*Power, Dusseldorf, Germany). With a 5-point composite score, the study should be able to detect a difference of 1.5 assuming SD of 0.75, alpha 5%, and power 80% with 12 teams. Given the uncertainty in the estimate of average time to treatment, the investigators will aim to recruit an additional 3 team for a total of 14 teams (42 individuals).
Regarding qualitative analysis, the investigators expect to reach the point of data saturation between 10 to 12 groups (no new themes are identified). Our justification for this sample is somewhat pragmatic but it is also expected that the variety and quality of responses will be greater than individual interviews given multiple participants in a team, and the learner-centered debriefing style led by expert debriefers. Furthermore, this sample size is consistent with previous research on team functioning in medical simulation.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jonathan G Bailey
- Phone Number: 902-473-4326
- Email: jon.bailey@dal.ca
Study Contact Backup
- Name: Sharon Amey
- Phone Number: 902-473-4337
- Email: SharonE1.Amey@nshealth.ca
Study Locations
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3K 5X5
- Recruiting
- Willow Park Armoury
-
Contact:
- Justin Richard
- Phone Number: (902) 427-3085
- Email: justincrichard@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Medical students from Dalhousie University and Canadian Armed Forces (CAF) medical technicians or nurses at a minimum of Rank Qualification Medical Technician Private
Exclusion Criteria:
- prior experience and training in regional anesthesia techniques
- visual/auditory impairments that make unmodified video chats difficult
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Real-time communication
|
In the no communication delay condition, the treating team of participants and mission control will be connected by real-time video chat.
The video chat will be turned on and available once the participants start the scenario.
The chat will remain on throughout the scenario.
|
|
Experimental: Delayed communication
|
In the communication delay condition, there will be a 80-second induced delay between each transmission of communication.
Both the treating team and mission control can send more than one message at a time, but the minimum delay will be maintained between receiving each individual message.
The number and frequency of messages will not be restrained.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to nerve block
Time Frame: Day 1
|
The investigators will measure the time to finish the block, defined as the time from the transducer first touching the patient to when the participant identifies where they would place the local anesthetic.
|
Day 1
|
|
Time to medical intervention
Time Frame: Day 1
|
The investigators will also record the time to medical intervention, defined as the time from a change in vital signs until definitive treatment (e.g.
epinephrine for anaphylaxis, lipid emulsion for LAST).
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ease of image acquisition
Time Frame: Day 1
|
Following the scenario but before the debrief, each participant will rate the ease of ultrasound image acquisition using a 5-point Likert scale (1 = very difficult, 2 = difficult, 3 = neutral, 4 = easy, 5 = very easy).
|
Day 1
|
|
Ease of communication
Time Frame: Day 1
|
Following the scenario but before the debrief, each participant will rate the ease of communication using a 5-point Likert scale (1 = very difficult, 2 = difficult, 3 = neutral, 4 = easy, 5 = very easy).
|
Day 1
|
|
Composite emergency medical treatment
Time Frame: Day 1
|
The completeness of essential treatments for the medical emergencies will be assessed using a composite score (Anaphylaxis: Fluid resus + Epinephrine + Secondary meds + O2/vent support; LAST: Identification of LAST + Intralipid + Midaz + O2/vent support)
|
Day 1
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qualitative communication themes
Time Frame: Day 1
|
The debriefing discussion will be audio recorded and later transcribed.
Data transcription will occur as soon as possible after each interview.
Transcripts of interviews will be later analyzed using thematic analysis.
|
Day 1
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NSH REB File#: 1031380
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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