Continuous Manual Chest Compressions With Asynchronous Ventilations Using the I-gel Device Versus 30:2 Current Practice Approach With Face Mask Ventilations During Simulated OHCA: Manikin Multicentre Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Chest compressions fraction (CCF) over the first 2 minutes of CPR
研究概览
简要总结
Paramedics and EMT will be recruited among four Emergency Medical Services (EMS) in Switzerland to manage a 10-minutes simulation-based adult out-of-hospital cardiac arrest scenario in teams of two. Depending on randomization, each team will manage the scenario according either to their current approach (30 compressions with 2 bag-mask ventilations), or to the experimental approach (continuous compressions since the start of CPR except for rhythm analysis and shock delivering, with early insertion of an i-gel® device to deliver asynchronous ventilations). The main hypothesis is that early insertion of i-gel could improve CCF during out-of-hospital cardiac arrest, with a reasonable time to first effective ventilation.
详细描述
Pre-scenario standardized workshop:
First, information about the study will be given and participants' questions are answered. Written consent will be obtained and the first part of the questionnaire individually completed. Participants will be told that the resuscitation scenario will be stopped after 10 minutes, independently of their actions and that no feedback will be given.
Then, the use of i-gel® device use will be taught by one of the investigators (LSt) in accordance with Peyton's approach because this approach has shown superiority, and based on a standard operating procedure created by study investigators following manufacturer's instructions:
- The instructor performs a complete insertion sequence in real-time without any comments;
- The instructor performs an insertion sequence with step-by-step explanations (description of key points);
- The learners guide the instructor step by step to perform the insertion;
- The learners do the complete insertion sequence then feedback could be given. They will perform this step a maximum of 3 times.
This workshop will last 20 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
During pre-scenario sessions (device workshop and 20-minute self-training session) the teams will not have been allocated to one of the study paths.
Allocation will be discovered as late as possible (after manikin's and defibrillatory characteristics presentation as well as the simulated patient's condition is given). From the moment of the allocation, it will be no more contact between investigators and participants. Due to the nature of the study with us of a supraglottic device, we are not able to blind participants, however they will be unaware of study outcomes. Assessment bias will be limited by using a high-fidelity manikin (SimMan 3G, Laerdal®, Stavanger, Norway) to collect study outcomes. Data analyst will be blinded to group allocation.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be a registered paramedic or EMT
- •To have previously completed the 20-minute workshop on how using the device by on of the study investigators
- •To have previously completed the 20-minute self-training session following a video recorded by the study investigators
- •Participation agreement
排除标准
- •Member of the study investigators
- •To have not undergone the 20-minute workshop
- •To have not watch the video
结局指标
主要结局
Chest compressions fraction (CCF) over the first 2 minutes of CPR
时间窗: At the end of Cycle 1 (each cycle is 2 minutes)
Proportion of time where compressions are performed during the first two minutes of the scenario
次要结局
- Time to first effective ventilation(10 minutes of scenario)
- CCF of fifth cycle(At the end of Cycle 5 (each cycle is 2 minutes))
- Overall CCF(10 minutes of scenario)
- Chest compressions depth(10 minutes of scenario)
- Number of delivered ventilations(10 minutes of scenario)
- CCF of second cycle(At the end of Cycle 2 (each cycle is 2 minutes))
- Proportions of compressions above, below and in the depth target(10 minutes of scenario)
- Chest compressions frequency(10 minutes of scenario)
- Chest compression relaxation(10 minutes of scenario)
- CCF of third cycle(At the end of Cycle 3 (each cycle is 2 minutes))
- Time to first shock(10 minutes of scenario)
- Ventilations volume(10 minutes of scenario)
- Proportions of ventilations above, below and in the volume target(10 minutes of scenario)
- CCF of fourth cycle(At the end of Cycle 4 (each cycle is 2 minutes))
- Proportions of compressions above, below and in the frequency target(10 minutes of scenario)
- User satisfaction assessed by a 5-point Likert scale ranging from "Not satisfied" to "Very satisfied"(10 minutes of scenario)
- Self-assessed cognitive load using a 9-point scale ranging from "Very, very low mentale effort" to "Very, very high mental effort"(10 minutes of scenario)
研究者
Stuby Loric
Paramedic with Certificate of Advanced Studies in Patient Oriented Clinical Research
Geneve TEAM Ambulances