Does the Choice of Personal Protective Equipment Affect Team Performance During Medical Emergencies? Simulation-Based Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 22
- 主要终点
- The Team Emergency Assessment Measure score (TEAM score)
研究概览
简要总结
Safety of healthcare professionals working in high-risk environments is of upmost importance. Personal protective equipment (PPE) may affect the performance of individuals and teams by altering their senses, manual skills and ability to communicate. Current guidelines offer flexibility in terms of which specific PPE components can safely be used. Yet, in some organisations, healthcare workers become used to using PPE well above the recommended standards (termed further in text as super-safe setup, SSS). Impact of this PPE policy on team performance and in turn to patient safety is unknown. The investigators hypothesise that SSS, as compared to WHO PPE standard, would negatively impact team performance and patient outcomes in a simulated crisis scenario.
详细描述
Safety of healthcare professionals working in high-risk environments is of upmost importance. Personal protective equipment (PPE) may affect the performance of individuals and teams by altering their senses, manual skills and ability to communicate. Current guidelines (WHO, UK, ECDC) offer flexibility in terms of which specific PPE components can safely be used. Yet, in some organisations, healthcare workers become used to using PPE well above the recommended standards (termed further in text as super-safe setup, SSS). Impact of this PPE policy on team performance and in turn to patient safety is unknown. The investigators hypothesise that SSS, as compared to WHO PPE standard, would negatively impact team performance and patient outcomes in a simulated crisis scenario.
Methods Design: prospective, open, randomised, controlled, parallel group trial, fully compliant with CONSORT guidelines with extension for simulation studies.
Study subjects: doctors and nurses routinely working in intensive care, written prospective informed consent Setting: High-fidelity simulation centre, Third Faculty of Medicine, Charles University in Prague
PPE tested
- WHO group (CONTROL): uses polycarbonate safety spectacles, fluid-resistant (Type IIR) surgical mask and disposable surgical gown. One pair of gloves. No head or foot cover.
- SSS group: Uses surgical cap, FFP3 respirator covered by surgical mask, face shield, whole-body suit (Tyvec), 3 pairs of gloves typed to suit sleeves and disposable foot cover
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinding of participants and researchers involved in the experiment is not possible. Only the outcome assessor and data analyst is kept blinded to the allocation of subjects.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Emergency Medicine (EM) and Anesthesiology and Critical Care (ACC) physicians
- •Emergency Medicine (EM) and Anesthesiology and Critical Care (ACC) nurses
- •Preparation and study of sent educational materials
- •Fulfillment of the whole complete simulation
排除标准
- •Not giving or withdrawal of the informed consent
- •Not willing to participate
- •Incomplete data acqusition
结局指标
主要结局
The Team Emergency Assessment Measure score (TEAM score)
时间窗: During the intervention
The TEAM questionaire will be used and will address following items: 1) the team leader let the team know what was expected of them through direction and command, 2) the team leader maintained a global perspective, 3) the team communicated effectively, 4) the team worked together to complete tasks in a timely manner, 5) the team acted with composure and control, 6) the team morale was positive, 7)the team adapted to changing situations, 8) the team monitored and reassessed the situation, 9) the team anticipated potential actions, 10) the team prioritized tasks, 11) the team followed approved standards/guidelines and 12) the global score. The TEAM items 1 - 11 will be rated using a five-point scale (range 0-4; 0 never/hardly ever, 1 seldom, 2 about as often as not, 3 often, 4 always/nearly always). The item 12 (global score) - the overall performance will be rated on scale from 1 to 10 (best). The mean for each item will be calculated.
次要结局
- Time to first chest compression(During the intervention)
- Chest compression frequency(During the intervention)
- Time to first epinephrine dose administration(During the intervention)
- Time to first effective breath after reintubation(During the intervention)
- Chest compression depth(During the intervention)
研究者
Roman Sýkora
assistant professor
Charles University, Czech Republic