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Completed

NCT Number: NCT04736446

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

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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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Genève TEAM Ambulances

Geneva, 1201, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

I-gel® supraglottic device

Device

Use of an i-gel® supraglottic device to deliver ventilations

Face mask ventilation

Device

Use of a face mask to deliver ventilations

Primary outcomes

  1. Chest compressions fraction (CCF) over the first 2 minutes of CPR

    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

Secondary outcomes

  1. CCF of second cycle

    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

  2. CCF of third cycle

    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

  3. CCF of fourth cycle

    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

  4. CCF of fifth cycle

    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

  5. Overall CCF

    Time frame: 10 minutes of scenario

    Proportion of time where compressions are performed during the entire scenario

  6. Chest compressions depth

    Time frame: 10 minutes of scenario

    Mean depth of compressions

  7. Proportions of compressions above, below and in the depth target

    Time frame: 10 minutes of scenario

    The depth target is 5 to 6 cm

  8. Chest compressions frequency

    Time frame: 10 minutes of scenario

    Mean frequency of compressions

  9. Proportions of compressions above, below and in the frequency target

    Time frame: 10 minutes of scenario

    The frequency target is 100 to 120 compressions by minute

  10. Time to first shock

    Time frame: 10 minutes of scenario

    Interval between start of compressions and delivering of first shock

  11. Time to first effective ventilation

    Time frame: 10 minutes of scenario

    Interval between start of compressions and delivering of first effective ventilation (defined as volume >300 ml)

  12. Ventilations volume

    Time frame: 10 minutes of scenario

    Mean volume of ventilations

  13. Proportions of ventilations above, below and in the volume target

    Time frame: 10 minutes of scenario

    The volume target is 300 to 700 ml

  14. User satisfaction assessed by a 5-point Likert scale ranging from "Not satisfied" to "Very satisfied"

    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"

  15. Self-assessed cognitive load using a 9-point scale ranging from "Very, very low mentale effort" to "Very, very high mental effort"

    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),

  16. Chest compression relaxation

    Time frame: 10 minutes of scenario

    Proportion of correct compressions (with less than 5 mm deviation from reference value)

  17. Number of delivered ventilations

    Time frame: 10 minutes of scenario

    Absolute number of delivered ventilations

Sponsors and collaborators

Lead sponsor

Geneve TEAM Ambulances

Other

Collaborators

  • Ambulance Riviera, Emergency Medical Services, La Tour-de-Peilz, Switzerland
  • Compagnie d'Ambulances de l'Hôpital du Valais, Emergency Medical Services, Martigny, Switzerland
  • ESAMB - College of Higher Education in Ambulance Care, Geneva, Switzerland
  • STAR Ambulances, Emergency Medical Services, Épalinges, Vaud
  • Service de protection et sauvetage Lausanne (SPSL), Emergency Medical Services, Switzerland
  • Swissrescue.ch, Website for Prehospital Healthcare Providers, Les Pontins, Switzerland

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 3, 2021
Registry last updated
Nov 12, 2024

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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