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

• ClinicalTrials.gov Identifier: NCT04736446
• Recruitment Status: Completed
• First Posted: February 3, 2021
• Last Update Posted: June 10, 2021
• Sponsor: Geneve TEAM Ambulances
• Collaborators: Service de protection et sauvetage Lausanne (SPSL), Emergency Medical Services, Switzerland; Ambulance Riviera, Emergency Medical Services, La Tour-de-Peilz, Switzerland; Compagnie d'Ambulances de l'Hôpital du Valais, Emergency Medical Services, Martigny, Switzerland; Swissrescue.ch, Website for Prehospital Healthcare Providers, Les Pontins, Switzerland; ESAMB - College of Higher Education in Ambulance Care, Geneva, Switzerland; STAR Ambulances, Emergency Medical Services, Épalinges, Vaud
• Information provided by (Responsible Party): Stuby Loric, Geneve TEAM Ambulances

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cardiac Arrest; Cardiopulmonary Arrest; Emergency Medical Services; Resuscitation	Device: I-gel® supraglottic device; Device: Face mask ventilation	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective, multicenter, randomized, controlled trial
• Masking: Double (Participant, Outcomes Assessor)

Masking Description

During pre-scenario sessions (device workshop and 20-minute self-training session) the teams will not have been allocated to one of the study paths.

Allocation will be discovered as late as possible (after manikin's and defibrillatory characteristics presentation as well as the simulated patient's condition is given). From the moment of the allocation, it will be no more contact between investigators and participants. Due to the nature of the study with us of a supraglottic device, we are not able to blind participants, however they will be unaware of study outcomes. Assessment bias will be limited by using a high-fidelity manikin (SimMan 3G, Laerdal®, Stavanger, Norway) to collect study outcomes. Data analyst will be blinded to group allocation.

• Primary Purpose: Treatment
• 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
• Actual Study Start Date: February 14, 2021
• Actual Primary Completion Date: May 18, 2021
• Actual Study Completion Date: May 18, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Switzerland

Genève TEAM Ambulances

Geneva, Switzerland, 1201

Sponsors and Collaborators

Geneve TEAM Ambulances

Service de protection et sauvetage Lausanne (SPSL), Emergency Medical Services, Switzerland

Ambulance Riviera, Emergency Medical Services, La Tour-de-Peilz, Switzerland

Compagnie d'Ambulances de l'Hôpital du Valais, Emergency Medical Services, Martigny, Switzerland

Swissrescue.ch, Website for Prehospital Healthcare Providers, Les Pontins, Switzerland

ESAMB - College of Higher Education in Ambulance Care, Geneva, Switzerland

STAR Ambulances, Emergency Medical Services, Épalinges, Vaud

Investigators

• Principal Investigator: Loric Stuby; Genève TEAM Ambulances

More Information

• Responsible Party: Stuby Loric, Paramedic with Certificate of Advanced Studies in Patient Oriented Clinical Research, Geneve TEAM Ambulances
• ClinicalTrials.gov Identifier: NCT04736446
• Other Study ID Numbers: CPR-1
• First Posted: February 3, 2021
• Last Update Posted: June 10, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: All collected IPD will be deposited on Mendeley Data
• Supporting Materials: Informed Consent Form (ICF)
• Time Frame: Starting 6 months after publication for at least two years
• Access Criteria: Open access on https://data.mendeley.com/

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Heart Arrest; Emergencies; Disease Attributes; Pathologic Processes; Heart Diseases; Cardiovascular Diseases