Clinical trial NCT04736446: Continuous Compressions With Asynchronous Ventilations Using I-gel Device Versus 30:2 Approach During Simulated OHCA
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Cardiopulmonary Arrest
Emergency Medical Services
Resuscitation
Lead sponsor: Geneve TEAM Ambulances
Sponsor class: OTHER
Collaborators: name: Service de protection et sauvetage Lausanne (SPSL), Emergency Medical Services, Switzerland
name: Ambulance Riviera, Emergency Medical Services, La Tour-de-Peilz, Switzerland
name: Compagnie d'Ambulances de l'Hôpital du Valais, Emergency Medical Services, Martigny, Switzerland
name: Swissrescue.ch, Website for Prehospital Healthcare Providers, Les Pontins, Switzerland
name: ESAMB - College of Higher Education in Ambulance Care, Geneva, Switzerland
name: STAR Ambulances, Emergency Medical Services, Épalinges, Vaud
First posted: 2021-02-03
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multicenter, randomized, controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Chest compressions fraction (CCF) over the first 2 minutes of CPR
timeFrame: At the end of Cycle 1 (each cycle is 2 minutes)
Secondary outcomes:
measure: CCF of second cycle
timeFrame: At the end of Cycle 2 (each cycle is 2 minutes)
measure: CCF of third cycle
timeFrame: At the end of Cycle 3 (each cycle is 2 minutes)
measure: CCF of fourth cycle
timeFrame: At the end of Cycle 4 (each cycle is 2 minutes)
measure: CCF of fifth cycle
timeFrame: At the end of Cycle 5 (each cycle is 2 minutes)
measure: Overall CCF
timeFrame: 10 minutes of scenario
measure: Chest compressions depth
timeFrame: 10 minutes of scenario
measure: Proportions of compressions above, below and in the depth target
timeFrame: 10 minutes of scenario
measure: Chest compressions frequency
timeFrame: 10 minutes of scenario
measure: Proportions of compressions above, below and in the frequency target
timeFrame: 10 minutes of scenario
measure: Time to first shock
timeFrame: 10 minutes of scenario
measure: Time to first effective ventilation
timeFrame: 10 minutes of scenario
measure: Ventilations volume
timeFrame: 10 minutes of scenario
measure: Proportions of ventilations above, below and in the volume target
timeFrame: 10 minutes of scenario
measure: User satisfaction assessed by a 5-point Likert scale ranging from "Not satisfied" to "Very satisfied"
timeFrame: 10 minutes of scenario
measure: Self-assessed cognitive load using a 9-point scale ranging from "Very, very low mentale effort" to "Very, very high mental effort"
timeFrame: 10 minutes of scenario
measure: Chest compression relaxation
timeFrame: 10 minutes of scenario
measure: Number of delivered ventilations
timeFrame: 10 minutes of scenario
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Genève TEAM Ambulances
Study officials:
affiliation: Genève TEAM Ambulances
name: Loric Stuby
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stuby L, Jampen L, Sierro J, Paus E, Spichiger T, Suppan L, Thurre D. Effect on Chest Compression Fraction of Continuous Manual Compressions with Asynchronous Ventilations Using an i-gel(R) versus 30:2 Approach during Simulated Out-of-Hospital Cardiac Arrest: Protocol for a Manikin Multicenter Randomized Controlled Trial. Healthcare (Basel). 2021 Mar 20;9(3):354. doi: 10.3390/healthcare9030354.
citation: Stuby L, Suppan L, Jampen L, Thurre D. Impact of the Over-the-Head Position with a Supraglottic Airway Device on Chest Compression Depth and Rate: A Post Hoc Analysis of a Randomized Controlled Trial. Healthcare (Basel). 2022 Apr 13;10(4):718. doi: 10.3390/healthcare10040718.
citation: Stuby L, Jampen L, Sierro J, Bergeron M, Paus E, Spichiger T, Suppan L, Thurre D. Effect of Early Supraglottic Airway Device Insertion on Chest Compression Fraction during Simulated Out-of-Hospital Cardiac Arrest: Randomised Controlled Trial. J Clin Med. 2021 Dec 31;11(1):217. doi: 10.3390/jcm11010217.