Continuous Compressions With Asynchronous Ventilations Using I-gel Device Versus 30:2 Approach During Simulated OHCA

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Self-managed training session: After the workshop, each team will have 20 minutes to self-train the introduction of the device in the complete OHCA management sequence on a CPR manikin permitting airway management. They will be supported by a demonstration video, which they could use freely. Resuscitation scenario: When entering the study room, an overview of the characteristics of the simulation manikin and the use of the defibrillator will be given through a standardized video. The team will then be asked to perform a 10-minutes highly realistic adult CPR scenario on a high-fidelity WiFi manikin. The procedure will be standardized across all sites to ensure that each participant is exposed to exactly the same case, with similar challenges in decision-making and treatment provided on the same manikin. The uniform delivery of the scenario throughout the entire study will minimize confounders. The room will be exclusively devoted to the simulation to prevent unexpected interruptions or external stimuli. The scenario will start with a clinical statement to recognize the life-threatening condition of the patient, given by one of the investigators as follows:  Here is Michael, a 50-years old who suddenly collapsed 10 minutes ago. He is now unconscious, pale and seems not breathing. The medical reinforcement is already underway and will be on site in about ten minutes. No first responder were dispatched to the scene and there is no bystander . The team leader will be asked to reformulate this statement (closed-loop communication) to ensure comprehension. He will then open the following envelope of the stack. The opaque, sealed envelope will contain the approach they will have to apply: standard care or experimental approach. From this point on, there will be no more contact between the participants and the study team, except to stop the scenario. If the participant checks the breathing, the patient will be apneic and pulse will be absent if checked. The first compression will be defined as T0. After placement of the pads, the defibrillator's display will show ventricular fibrillation (VF). All following rhythm analyses will show refractory VF, regardless of whether a shock is delivered. To increase simulation's fidelity, CPR waves will be displayed when compressions will be delivered. Participants will be able to obtain an intravenous access on first attempt. They should administer first 1 mg of epinephrine (at the earliest after the second shock), then a first-dose of amiodarone or lidocaine following local protocols (in accordance with the 2020 AHA cardiac arrest algorithm. The scenario will be stopped exactly 10 minutes after the first compression. There will be no feedback after the study period.

Official Title
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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

Conditions
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Cardiac Arrest, Cardiopulmonary Arrest, Emergency Medical Services, Resuscitation

Intervention / Treatment
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* Device: I-gel® supraglottic device
* Device: Face mask ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Member of the study investigators To have not undergone the 20-minute workshop To have not watch the video
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, multicenter, randomized, controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I-gel® group<br>Continuous chest compressions from the start of the CPR with early i-gel® device insertion and asynchronous ventilations | Device: I-gel® supraglottic device<br>* Use of an i-gel® supraglottic device to deliver ventilations<br>|
| Other: Standard group<br>Basic (standard) management by using a ratio of 30 compressions and 2 face mask ventilations | Device: Face mask ventilation<br>* Use of a face mask to deliver ventilations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest compressions fraction (CCF) over the first 2 minutes of CPR | Proportion of time where compressions are performed during the first two minutes of the scenario | At the end of Cycle 1 (each cycle is 2 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CCF of second cycle | Proportion of time where compressions are performed during the following two minutes of the scenario | At the end of Cycle 2 (each cycle is 2 minutes) | 
| CCF of third cycle | Proportion of time where compressions are performed during the following two minutes of the scenario | At the end of Cycle 3 (each cycle is 2 minutes) | 
| CCF of fourth cycle | Proportion of time where compressions are performed during the following two minutes of the scenario | At the end of Cycle 4 (each cycle is 2 minutes) | 
| CCF of fifth cycle | Proportion of time where compressions are performed during the following two minutes of the scenario | At the end of Cycle 5 (each cycle is 2 minutes) | 
| Overall CCF | Proportion of time where compressions are performed during the entire scenario | 10 minutes of scenario | 
| Chest compressions depth | Mean depth of compressions | 10 minutes of scenario | 
| Proportions of compressions above, below and in the depth target | The depth target is 5 to 6 cm | 10 minutes of scenario | 
| Chest compressions frequency | Mean frequency of compressions | 10 minutes of scenario | 
| Proportions of compressions above, below and in the frequency target | The frequency target is 100 to 120 compressions by minute | 10 minutes of scenario | 
| Time to first shock | Interval between start of compressions and delivering of first shock | 10 minutes of scenario | 
| Time to first effective ventilation | Interval between start of compressions and delivering of first effective ventilation (defined as volume >300 ml) | 10 minutes of scenario | 
| Ventilations volume | Mean volume of ventilations | 10 minutes of scenario | 
| Proportions of ventilations above, below and in the volume target | The volume target is 300 to 700 ml | 10 minutes of scenario | 
| User satisfaction assessed by a 5-point Likert scale ranging from Not satisfied to Very satisfied | User satisfaction regarding applied approach assessed on 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 | Self-reported cognitive load during resuscitation scenario assessed using a 9-point symmetrical category scale which ranged from Very, very low mental effort (1) to Very, very high mental effort (9), | 10 minutes of scenario | 
| Chest compression relaxation | Proportion of correct compressions (with less than 5 mm deviation from reference value) | 10 minutes of scenario | 
| Number of delivered ventilations | Absolute number of delivered ventilations | 10 minutes of scenario |