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

NCT04736446 | Completed

• 1 other identifier: CPR-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest; Cardiopulmonary Arrest; Emergency Medical Services; Resuscitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• CCF of second cycle

  At the end of Cycle 2 (each cycle is 2 minutes)

• CCF of third cycle

  At the end of Cycle 3 (each cycle is 2 minutes)

• CCF of fourth cycle

  At the end of Cycle 4 (each cycle is 2 minutes)

• CCF of fifth cycle

  At the end of Cycle 5 (each cycle is 2 minutes)

• Overall CCF

  10 minutes of scenario

Study Arms (2)

I-gel® group

EXPERIMENTAL

Continuous chest compressions from the start of the CPR with early i-gel® device insertion and asynchronous ventilations

Device: I-gel® supraglottic device

Standard group

OTHER

Basic (standard) management by using a ratio of 30 compressions and 2 face mask ventilations

Device: Face mask ventilation

Interventions

I-gel® supraglottic device DEVICE

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

I-gel® group

Face mask ventilation DEVICE

Use of a face mask to deliver ventilations

Standard group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Member of the study investigators
• To have not undergone the 20-minute workshop
• To have not watch the video

Sponsors & Collaborators

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

Study Sites (1)

Genève TEAM Ambulances

Geneva, 1201, Switzerland

Location

Related Publications (3)

• 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.

  PMID: 33804664 BACKGROUND

• 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.

  PMID: 35455895 BACKGROUND

• 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.

  PMID: 35011958 RESULT

Related Links

• Whole project website

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Loric Stuby

  Genève TEAM Ambulances

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Paramedic with Certificate of Advanced Studies in Patient Oriented Clinical Research

Model Details: Prospective, multicenter, randomized, controlled trial

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: February 3, 2021
• Study Start: February 14, 2021
• Primary Completion: May 18, 2021
• Study Completion: May 18, 2021
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Starting 6 months after publication for at least two years
• Access Criteria: Open access on https://data.mendeley.com/

Locations

CH (1)