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OpenTrials
Completed

NCT Number: NCT05709613

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ACE Genève Ambulances, Chêne-Bougeries, Canton of Geneva, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Use of a chest compressions' feedback device

Device

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

Primary outcomes

  1. Compressions within the depth target

    Time frame: Through study completion, i.e.10 minutes of scenario.

    Proportions of compressions within the depth target of 5 to 6 centimeters

Secondary outcomes

  1. Overall chest compression fraction

    Time frame: Through 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

  2. Depth of chest compressions

    Time frame: Through study completion, i.e.10 minutes of scenario.

    The depth of chest compressions measured in centimeters

  3. Compressions within the rate target

    Time frame: Through study completion, i.e.10 minutes of scenario.

    Proportions of compressions within the rate target of 100 to 120 compressions per minute

  4. Rate of chest compressions

    Time frame: Through study completion, i.e.10 minutes of scenario.

    The rate of chest compressions measured in compressions per minute

  5. Compressions with correct chest recoil

    Time frame: Through 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)

  6. Time to first effective ventilation

    Time frame: Through 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)

Sponsors and collaborators

Lead sponsor

Geneve TEAM Ambulances

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 2, 2023
Registry last updated
Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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