Cardiac Arrest Clinical Trial
Official title:
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
NCT number | NCT05709613 |
Other study ID # | CPR-7 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 30, 2023 |
Est. completion date | June 13, 2023 |
Verified date | September 2023 |
Source | Geneve TEAM Ambulances |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | June 13, 2023 |
Est. primary completion date | June 13, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | ACE Genève Ambulances | Chêne-Bougeries | Geneva |
Switzerland | Genève TEAM Ambulances | Geneva | |
Switzerland | SK Ambulances | Geneva | |
Switzerland | Ambulances de la Ville de Sion | Sion | Valais |
Lead Sponsor | Collaborator |
---|---|
Geneve TEAM Ambulances |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | |
Secondary | Depth of chest compressions | The depth of chest compressions measured in centimeters | Through study completion, i.e.10 minutes of scenario. | |
Secondary | 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. | |
Secondary | Rate of chest compressions | The rate of chest compressions measured in compressions per minute | Through study completion, i.e.10 minutes of scenario. | |
Secondary | 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. | |
Secondary | 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. |
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