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临床试验/NCT07675863
NCT07675863招募中不适用

The Impact of Communication Delays on Anesthesia Response to Medical Emergencies and Ultrasound-Guided Regional Anesthesia: A Randomized Simulation Study

Nova Scotia Health Authority1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2026年7月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
42
试验地点
1
主要终点
Time to nerve block

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • prior experience and training in regional anesthesia techniques
  • visual/auditory impairments that make unmodified video chats difficult

结局指标

主要结局

Time to nerve block

时间窗: 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.

Time to medical intervention

时间窗: 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).

次要结局

  • Ease of communication(Day 1)
  • Ease of image acquisition(Day 1)
  • Composite emergency medical treatment(Day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jon Bailey

Anesthesiologist

Nova Scotia Health Authority

研究点 (1)

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