Continuous Compressions With Asynchronous Ventilations Using I-gel Device Versus 30:2 Approach During Simulated OHCA
- Conditions
- Emergency Medical ServicesCardiac ArrestResuscitationCardiopulmonary Arrest
- Interventions
- Device: I-gel® supraglottic deviceDevice: Face mask ventilation
- Registration Number
- NCT04736446
- Lead Sponsor
- Geneve TEAM Ambulances
- Brief Summary
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
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:
1. The instructor performs a complete insertion sequence in real-time without any comments;
2. The instructor performs an insertion sequence with step-by-step explanations (description of key points);
3. The learners guide the instructor step by step to perform the insertion;
4. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- Member of the study investigators
- To have not undergone the 20-minute workshop
- To have not watch the video
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description I-gel® group I-gel® supraglottic device Continuous chest compressions from the start of the CPR with early i-gel® device insertion and asynchronous ventilations Standard group Face mask ventilation Basic (standard) management by using a ratio of 30 compressions and 2 face mask ventilations
- Primary Outcome Measures
Name Time Method Chest compressions fraction (CCF) over the first 2 minutes of CPR 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
- Secondary Outcome Measures
Name Time Method Time to first effective ventilation 10 minutes of scenario Interval between start of compressions and delivering of first effective ventilation (defined as volume \>300 ml)
CCF of fifth cycle At the end of Cycle 5 (each cycle is 2 minutes) Proportion of time where compressions are performed during the following two minutes of the scenario
Overall CCF 10 minutes of scenario Proportion of time where compressions are performed during the entire scenario
Chest compressions depth 10 minutes of scenario Mean depth of compressions
Number of delivered ventilations 10 minutes of scenario Absolute number of delivered ventilations
CCF of second cycle At the end of Cycle 2 (each cycle is 2 minutes) Proportion of time where compressions are performed during the following two minutes of the scenario
Proportions of compressions above, below and in the depth target 10 minutes of scenario The depth target is 5 to 6 cm
Chest compressions frequency 10 minutes of scenario Mean frequency of compressions
Chest compression relaxation 10 minutes of scenario Proportion of correct compressions (with less than 5 mm deviation from reference value)
CCF of third cycle At the end of Cycle 3 (each cycle is 2 minutes) Proportion of time where compressions are performed during the following two minutes of the scenario
Time to first shock 10 minutes of scenario Interval between start of compressions and delivering of first shock
Ventilations volume 10 minutes of scenario Mean volume of ventilations
Proportions of ventilations above, below and in the volume target 10 minutes of scenario The volume target is 300 to 700 ml
CCF of fourth cycle At the end of Cycle 4 (each cycle is 2 minutes) Proportion of time where compressions are performed during the following two minutes of the scenario
Proportions of compressions above, below and in the frequency target 10 minutes of scenario The frequency target is 100 to 120 compressions by minute
User satisfaction assessed by a 5-point Likert scale ranging from "Not satisfied" to "Very satisfied" 10 minutes of scenario User satisfaction regarding applied approach assessed on a 5-point Likert scale ranging from "Not satisfied" to "Very satisfied"
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 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),
Trial Locations
- Locations (1)
Genève TEAM Ambulances
🇨🇭Geneva, Switzerland