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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest; Emergency Medical Services; Resuscitation; Cardiopulmonary Arrest
• Intervention / Treatment: Device: I-gel® supraglottic device; Device: Face mask 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1201
    • Genève TEAM Ambulances

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chest compressions fraction (CCF) over the first 2 minutes of CPR	Proportion of time where compressions are performed during the first two minutes of the scenario	At the end of Cycle 1 (each cycle is 2 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CCF of second cycle	Proportion of time where compressions are performed during the following two minutes of the scenario	At the end of Cycle 2 (each cycle is 2 minutes)
CCF of third cycle	Proportion of time where compressions are performed during the following two minutes of the scenario	At the end of Cycle 3 (each cycle is 2 minutes)
CCF of fourth cycle	Proportion of time where compressions are performed during the following two minutes of the scenario	At the end of Cycle 4 (each cycle is 2 minutes)
CCF of fifth cycle	Proportion of time where compressions are performed during the following two minutes of the scenario	At the end of Cycle 5 (each cycle is 2 minutes)
Overall CCF	Proportion of time where compressions are performed during the entire scenario	10 minutes of scenario
Chest compressions depth	Mean depth of compressions	10 minutes of scenario
Proportions of compressions above, below and in the depth target	The depth target is 5 to 6 cm	10 minutes of scenario
Chest compressions frequency	Mean frequency of compressions	10 minutes of scenario
Proportions of compressions above, below and in the frequency target	The frequency target is 100 to 120 compressions by minute	10 minutes of scenario
Time to first shock	Interval between start of compressions and delivering of first shock	10 minutes of scenario
Time to first effective ventilation	Interval between start of compressions and delivering of first effective ventilation (defined as volume >300 ml)	10 minutes of scenario
Ventilations volume	Mean volume of ventilations	10 minutes of scenario
Proportions of ventilations above, below and in the volume target	The volume target is 300 to 700 ml	10 minutes of scenario
User satisfaction assessed by a 5-point Likert scale ranging from "Not satisfied" to "Very satisfied"	User satisfaction regarding applied approach assessed on a 5-point Likert scale ranging from "Not satisfied" to "Very satisfied"	10 minutes of scenario
Self-assessed cognitive load using a 9-point scale ranging from "Very, very low mentale effort" to "Very, very high mental effort"	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),	10 minutes of scenario
Chest compression relaxation	Proportion of correct compressions (with less than 5 mm deviation from reference value)	10 minutes of scenario
Number of delivered ventilations	Absolute number of delivered ventilations	10 minutes of scenario

Collaborators and Investigators

• 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Whole project website

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2021
• Primary Completion (Actual): May 18, 2021
• Study Completion (Actual): May 18, 2021

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 30, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 8, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Emergencies; Heart Arrest
• Other Study ID Numbers: CPR-1

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No