Genève TEAM Ambulances
Geneva, 1201, Switzerland
NCT Number: NCT04736446
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.
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Interventional
Not applicable
Geneva, 1201, Switzerland
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use of an i-gel® supraglottic device to deliver ventilations
Use of a face mask to deliver ventilations
Time frame: 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
Time frame: 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
Time frame: 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 frame: 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
Time frame: 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
Time frame: 10 minutes of scenario
Proportion of time where compressions are performed during the entire scenario
Time frame: 10 minutes of scenario
Mean depth of compressions
Time frame: 10 minutes of scenario
The depth target is 5 to 6 cm
Time frame: 10 minutes of scenario
Mean frequency of compressions
Time frame: 10 minutes of scenario
The frequency target is 100 to 120 compressions by minute
Time frame: 10 minutes of scenario
Interval between start of compressions and delivering of first shock
Time frame: 10 minutes of scenario
Interval between start of compressions and delivering of first effective ventilation (defined as volume >300 ml)
Time frame: 10 minutes of scenario
Mean volume of ventilations
Time frame: 10 minutes of scenario
The volume target is 300 to 700 ml
Time frame: 10 minutes of scenario
User satisfaction regarding applied approach assessed on a 5-point Likert scale ranging from "Not satisfied" to "Very satisfied"
Time frame: 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),
Time frame: 10 minutes of scenario
Proportion of correct compressions (with less than 5 mm deviation from reference value)
Time frame: 10 minutes of scenario
Absolute number of delivered ventilations
Geneve TEAM Ambulances
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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