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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05709613
Enrollment
34
Registered
2023-02-02
Start date
2023-01-30
Completion date
2023-06-13
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest, Cardiopulmonary Arrest, Emergency Medicine, Resuscitation

Brief summary

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.

Interventions

DEVICEUse of a chest compressions' feedback device

The participants will have access to a chest compressions' feedback device

Sponsors

Geneve TEAM Ambulances
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Data extraction will be fully automated and the statistician will not know the identity of the participants or the sequence they were allocated to.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Compressions within the depth targetThrough study completion, i.e.10 minutes of scenario.Proportions of compressions within the depth target of 5 to 6 centimeters

Secondary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026