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
NCT number | NCT04736446 |
Other study ID # | CPR-1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 14, 2021 |
Est. completion date | May 18, 2021 |
Verified date | January 2023 |
Source | Geneve TEAM Ambulances |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Genève TEAM Ambulances | Geneva |
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 |
Switzerland,
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
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 |
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