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

Cardiac Arrest Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04736446
• Other study ID #: CPR-1
• Status: Completed
• Phase: N/A
• Start date: February 14, 2021
• Est. completion date: May 18, 2021

Study information

• Verified date: January 2023
• Source: Geneve TEAM Ambulances
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 18, 2021
• Est. primary completion date: May 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Cardiopulmonary Arrest
• Emergencies
• Emergency Medical Services
• Heart Arrest
• Resuscitation

Intervention

Device:
• I-gel® supraglottic device
Use of an i-gel® supraglottic device to deliver ventilations
• Face mask ventilation
Use of a face mask to deliver ventilations

Locations

Country	Name	City	State
Switzerland	Genève TEAM Ambulances	Geneva

Sponsors (7)

Lead Sponsor

Collaborator

Geneve TEAM Ambulances

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, Service de protection et sauvetage Lausanne (SPSL), Emergency Medical Services, Switzerland, STAR Ambulances, Emergency Medical Services, Épalinges, Vaud, Swissrescue.ch, Website for Prehospital Healthcare Providers, Les Pontins, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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. — View 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. — View 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: 10.339 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Overall CCF	Proportion of time where compressions are performed during the entire scenario	10 minutes of scenario
Secondary	Chest compressions depth	Mean depth of compressions	10 minutes of scenario
Secondary	Proportions of compressions above, below and in the depth target	The depth target is 5 to 6 cm	10 minutes of scenario
Secondary	Chest compressions frequency	Mean frequency of compressions	10 minutes of scenario
Secondary	Proportions of compressions above, below and in the frequency target	The frequency target is 100 to 120 compressions by minute	10 minutes of scenario
Secondary	Time to first shock	Interval between start of compressions and delivering of first shock	10 minutes of scenario
Secondary	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
Secondary	Ventilations volume	Mean volume of ventilations	10 minutes of scenario
Secondary	Proportions of ventilations above, below and in the volume target	The volume target is 300 to 700 ml	10 minutes of scenario
Secondary	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
Secondary	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
Secondary	Chest compression relaxation	Proportion of correct compressions (with less than 5 mm deviation from reference value)	10 minutes of scenario
Secondary	Number of delivered ventilations	Absolute number of delivered ventilations	10 minutes of scenario

External Links

•   Whole project website