Use of a Feedback Device to Limit Too Shallow Compressions Associated With the Use of an I-gel® Device

Study Overview
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Brief Summary
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Airway management in out-of-hospital cardiac arrest is still debated. Several options exist: bag-valve-mask ventilation, supraglottic devices and endotracheal intubation. Intermediate and advanced airway management strategies could be useful devices to increase chest compression fraction. A previous study shows that early insertion of an i-gel device significantly increases chest compression fraction and enhances respiratory parameters. However, the compressions were found to be shallower in the experimental group using the i-gel device. Although, the shallower compressions found in the supraglottic airway device group did not appear to be linked to their provision in an over-the-head position, it is reasonable to assume that the addition of a feedback device to the use of an i-gel® device could fix this issue. The feedback devices seem to be able to provide a benefit, and allow deeper compressions / more often in the depth target. There is a mismatch between perceived and actual cardiopulmonary resuscitation performance supporting the need for such a feedback device's study.

Official Title
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Use of a Feedback Device to Limit Too Shallow Compressions Associated With the Use of an I-gel® Device During Simulated Out-of-Hospital Cardiac Arrest: Simulation-based Multicentre Randomised Controlled Trial

Conditions
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Cardiac Arrest, Cardiopulmonary Arrest, Resuscitation, Emergency Medicine

Intervention / Treatment
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* Device: Use of a chest compressions' feedback device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Registered EMTs and paramedics actively working in any of the participating study trial centers will be eligible for inclusion. Exclusion Criteria: Members of the study team EMTs will be randomly excluded if there are more EMTs than paramedics.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No feedback device<br>This group will have no access to the feedback device | |
| Experimental: Feedback device<br>This group will have access to the feedback device | Device: Use of a chest compressions' feedback device<br>* The participants will have access to a chest compressions' feedback device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compressions within the depth target | Proportions of compressions within the depth target of 5 to 6 centimeters | Through study completion, i.e.10 minutes of scenario. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall chest compression fraction | The chest compression fraction is the time during which compressions are provided divided by the total time of the resuscitation | Through study completion, i.e.10 minutes of scenario. | 
| Depth of chest compressions | The depth of chest compressions measured in centimeters | Through study completion, i.e.10 minutes of scenario. | 
| Compressions within the rate target | Proportions of compressions within the rate target of 100 to 120 compressions per minute | Through study completion, i.e.10 minutes of scenario. | 
| Rate of chest compressions | The rate of chest compressions measured in compressions per minute | Through study completion, i.e.10 minutes of scenario. | 
| Compressions with correct chest recoil | The proportions of compressions with complete chest recoil (less than 5 millimeters of deviation from the reference value) | Through study completion, i.e.10 minutes of scenario. | 
| Time to first effective ventilation | The time measured in seconds from beginning of the resuscitation to first effective ventilation (defined as at least 300 millilitres) | Through study completion, i.e.10 minutes of scenario. |